chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Joint injury, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Arm became very sore. So sore it was difficult to sleep or use my arm. I tried to wait to see if it would just get better, but it remained too sore to lift above shoulder level for 2 weeks. Symptoms have improved with regular NSAID use, but the muscles are still sore and the shoulder seems to have sustained an injury of some kind (it has now been a month). I am going to go to the doctor soon to see what is going on.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: On 10/17/13, patient was complaining that the morning after her shot her arm was sore and that it progressively worsened with soreness extending up into her posterior shoulder to her neck.  Her arm showed no redness or swelling on 10/17/13 when it was first reported to the vaccinator but patient states that it might have been the day before.  Patient reports no fever today but she feels like she could have possibly ran fever previously and that she feels like she has fever "on the inside."  Patient was referred to her primary care doctor and they gave her a ketorolac injection and muscle relaxers.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: Hives, nausea, vomiting; epi 0.5ml sq administered; EMS arrived and gave Benadryl.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal stiffness, Pain, Periarthritis
Clinical narrative: Pain, stiffness, weakness, frozen arm.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dysphonia, Ear congestion, Malaise, Nasal congestion
Clinical narrative: Intermittent fever, chills, body aches, nasal & ear stuffiness, runny nose, hoarseness, bed rest, malaise, continues after I week. 1,000 mg acetaminophen 2x daily for fever.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Intermittent fever, chills, body aches, nasal & ear stuffiness, runny nose, hoarseness, bed rest, malaise, continues after I week. 1,000 mg acetaminophen 2x daily for fever.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperphagia, Injection site pruritus, Injection site rash, Rash, Rash erythematous
Clinical narrative: Red rash developed gradually increasing:  beginning back of upper left arm (site of injection), increasing in size and itching over next 4 - 5 days to include back of right upper arm, chest, shoulder area, face (mask appearing) to tope of scalp.  Seen by medical provider.  Declined Benadryl capsules.  Rash persisted 10 - 14 days.  Gradually subsided by 3 weeks.  Treatment:  increased water intake.
Age: 1.06
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: High fever of 103 on/off for 2.5 days.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Lymph node pain, Pain, Pyrexia
Clinical narrative: Flu like symptons, achy, fever 101. At 3am temp 104 took 800 Motrin fever come down to 101.6. Fever broke Sunday 10/21 feem much better today lymph node under left arm tender.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Induration, Swelling
Clinical narrative: After I got home, the redness and swelling started.  Grew to about 8 inches long and 6 inches wide.  A very hard localized spot also appeared.  Went to the pharmacist and they said everything normal.  Huge blisters then appeared.  Went back to the pharmacist and she said I had zoster blisters.  I had to stay in bed for 3 days.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at site of injection, swelling and hot.  Later, severe joint and muscle pain and headache, some nausea and sleepiness.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Somnolence
Clinical narrative: Pain at site of injection, swelling and hot.  Later, severe joint and muscle pain and headache, some nausea and sleepiness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: Became extremely tired by noon. Woke up at 1:15 am 10/19/2013 with heart beating quickly and difficulty breathing, took 2 Benadryl, severe headache, weakness. Breathing and heartbeat back to normal within 30 - 45 minutes. Weakness and and tiredness continues through 10/21/2013.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Pt developed R upper arm swelling, redness several days following vaccine administration. Parent treated with warm compress at home. PO Childrens Ibuprofen and office eval 2-3 days following onset SX. No fever. No systemic symptoms. Pt evaluated 10/15/13 by PA. PO Benadryl advised continue Ibuprofen, ice for local reaction.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Flushing, Hepatic enzyme increased, Influenza like illness, Lethargy
Clinical narrative: Immediate metallic taste, increased thirst, throat sore, itchy ears, face flushed, flu like symptoms 10-16-13, 10-17-13. 10-18-13 BP 200/114, nausea, continued with itching, lethargy flu-like symptoms. 10-19-13 Went to ER was given Clonidine, diagnosed with serum sickness and sent home to follow up in 3-5d for repeat lab work.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pruritus, Serum sickness, Thirst
Clinical narrative: Immediate metallic taste, increased thirst, throat sore, itchy ears, face flushed, flu like symptoms 10-16-13, 10-17-13. 10-18-13 BP 200/114, nausea, continued with itching, lethargy flu-like symptoms. 10-19-13 Went to ER was given Clonidine, diagnosed with serum sickness and sent home to follow up in 3-5d for repeat lab work.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Influenza like illness, Middle insomnia
Clinical narrative: 10/10 1PM got shot. Midnight woke up with severe flu like symptoms 10/11 evening boyfriend called asking if normal. Trouble breathing recommended go to ER.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthma, Condition aggravated
Clinical narrative: Pt received influenza vaccine in am. In the afternoon during a soccer game, she had a severe asthma attack that appears to have been an anaphylactic reaction. No new foods or known exposures. Can not r/o flu vaccine as precipitation factor.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Headache, Hypoaesthesia, Local swelling
Clinical narrative: Starting evening of receiving vaccination SX included: lightheadedness, headache, diarrhea, N/V, fever, swollen/stiffness with numbness to fingers, stiff neck. SX lasted approx 48 hrs was evaluated by HCP 10-3-13 who diagnosed her with systemic RXN to Hep B vaccine. No allergic RXN. Given Ondansetron IM for nausea and APAP for fever/aches/pains.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: Starting evening of receiving vaccination SX included: lightheadedness, headache, diarrhea, N/V, fever, swollen/stiffness with numbness to fingers, stiff neck. SX lasted approx 48 hrs was evaluated by HCP 10-3-13 who diagnosed her with systemic RXN to Hep B vaccine. No allergic RXN. Given Ondansetron IM for nausea and APAP for fever/aches/pains.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Two hours after injection pain in upper left arm - Traveled down to hand and fingers - severe weakness worse at night cannot sleep or turn - has not subsided to this day - cannot hold anything heavier than a glass - affecting shoulder and neck.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: Patient completed all 4 capsules. Called pharmacist to report bumps and itching on hands and feet. Skin is peeling.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Severe abdominal pain, persistent vomiting in middle of night (3AM) until mid am after imm given late after noon (5:00 pm) imm given. Stopped vomiting at noon next day.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Patient threw up one time after 1st pill.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis 3 inch wide red mark in injection site area.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt had injection site reaction - according in NP she had mild redness and minor edema around injection site. She gave her 40mg IM of KENALOG to treat.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Blood pressure, Diarrhoea, Dizziness, Heart rate increased
Clinical narrative: Elevated pulse, blood pressure, fever, diarrhea, stomach upset, dizziness lasting 20 hours after shot given - onset of symptoms about 2-3 hours.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Elevated pulse, blood pressure, fever, diarrhea, stomach upset, dizziness lasting 20 hours after shot given - onset of symptoms about 2-3 hours.
Age: 17.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 2.8 cm swelling - red.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, Vagus nerve disorder, Visual impairment
Clinical narrative: Patient started experiencing dizziness and fatigue with some visual disturbances. Patient stated had only eaten a power bar for breakfast and immunization given around 1 pm. Patient conditions worsen called 911 and responded the ambulance did not take the patient to the hospital the husband did later and stop by the pharmacy to inform us of her diagnosis vagus nerve reaction.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Pt received PNEUMOVAX vaccine 10/2/13. She developed diffuse redness and swelling of (L) arm the next day. Redness started 4 inches below immunization site and extended 12 inches down (L) arm and redness was 4" wide. Seen in office 10/4/13 and was given prednisone 40 mg BID.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at inj site AUGMENTIN 875 1 BID #20.
Age: 1.57
Sex: M
Vaccine: MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 104 per report. Tylenol/Motrin given.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Swelling, bruising, redness.
Age: 18.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Rash, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Skin rash 3 days after getting influenza and varicella vaccines. Very itchy. Spread all over body. Wheal type. Better after taking BENADRYL.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Muscular weakness, Myositis
Clinical narrative: Muscle weakness (legs) myositis.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Local swelling, Pyrexia
Clinical narrative: Left upper arm swelling and slight rash x 3 days, fever x 1 day, swelling in (L) axilla area x 3 days.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Hyperhidrosis, Local swelling, Rash, Tremor
Clinical narrative: Vaccines administered on 10/18/13 in A.M. Diaphoretic and shaky by evening. Arm became swollen and red and developed rash. Reported seen at walk in clinic and ultimately admitted to hosp.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site mass
Clinical narrative: The patient experienced pronounced bleeding and then a small lump formed after the bleeding stopped at the injection site.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Vaccine administered on 10/12/13. Patient noticed red area where shot was administered on 10/14/13. No pain or itching, just very hard to the touch.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site bruising, Local swelling, Myalgia
Clinical narrative: Muscle aches, back pain, neck swelling, injection site bruising.
Age: 1.36
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: 8 vesicular lesions on torso.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Foetal distress syndrome, Foetal hypokinesia
Clinical narrative: Patient received TDAP and flu vaccine on 10/11/13. Reported decreased fetal movements next day presented on 10/14/13. Baby showed distress and was emergently delivered by C/S. Baby had severe acidosis with PH 6.9.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Ocular hyperaemia, Tremor
Clinical narrative: Extreme fatigue. Redness of eyes. Body chills. Shaking. Headache. Symptoms self resolved over the course of 2 days.
Age: 2.0
Sex: M
Vaccine: FLUN4, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Red dime size swollen lump in left leg. Painful to the touch and to walk on leg.
Age: 4.0
Sex: M
Vaccine: DTPIPV, FLUN4, MMRV
Symptoms: Abscess, Abscess limb, Culture wound positive, Incisional drainage, Pyrexia
Clinical narrative: Patient developed a large abscess of his left deltoid and fever to 40.5 requiring inpateint admission with IV antibiotics and surgery for I & D.
Age: 4.0
Sex: M
Vaccine: DTPIPV, FLUN4, MMRV
Symptoms: Streptococcus test, Streptococcus test positive
Clinical narrative: Patient developed a large abscess of his left deltoid and fever to 40.5 requiring inpateint admission with IV antibiotics and surgery for I & D.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Urticaria
Clinical narrative: 2 DAYS AFTER VACCINE DEVELOPED LOCAL REACTION, WITH SWELLING AND WARMTH AT SITE, THEN STARTED HAVING HIVES ALL OVER THE BODY OVER THE NEXT 2 DAYS.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Paraesthesia
Clinical narrative: One hour after arising, she was unable to move her right arm, and had pins and needles.  Symptoms persist intermittently.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pruritus, Headache, Laryngitis, Throat irritation
Clinical narrative: I developed a headache shortly after the shot was administered.  The headache lasted all day 10/14 and all day 10/15.  On 10/16 my eyes were itchy all day.  On 10/17 my throat started to bother me.  10/18, 10/19, 10/20, and 10/21 I developed laryngitis.  On 10/20 I also developed a very heavy feeling in my chest.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Pt calling to report sxs following her 10/18 shingles vaccine at her Px. Reports an area of redness at the injection site measuring 1.5 inches in addition to a blistery rash at her right wrist measuring 2 inches long and 1 inch wide.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient reported itchy rash described as hives on the injected arm over a period of several days. Self-treated with witch hazel. Advised BENADRYL cr. could be used.
Age: 1.22
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Emotional distress, Feeding disorder of infancy or early childhood, Hypokinesia, Screaming
Clinical narrative: Child was screaming an crying uncontroably, (very unlike him). Would not allow to be picked up, would not eat or breastfeed. Would not sit up. Would not move anythig from waist down, (even when sleeping- which is very unlike him considering he rolls around a lot), called dr and was advised to give children's Motrin at 8pm and to call back if nothing changed. Nothing changed so called dr back and was advised to take child to ER. Went to ER around 2am. Same symptoms this whole time (from 5pm-2am). Was seen by a Doctor in ER around 3am and symptoms seems to go away.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I have a large bruise, 3" by 1.5", around the injection site and a red patch, about 2" by 1", below the site. By the 3rd day, it itched a lot and on the 4th day is more sore.  The pharmacist said he hasn't seen a reaction like that.  I'm not allergic to eggs and have never had a reaction to a flu shot.  I hope it's not a bad batch of flu shots. I decided to report this because of other instances where the medications have been tainted.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Nausea, Pain, Pallor, Pyrexia
Clinical narrative: 101.5 fever, paleness, weakness, body aches, nausea.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red, non tender, non itchy rash (7 cm x 4.5 cm) distal to injection site.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Describes it similar to a torn tendon pain, lifting arm was painful, twisting an object such as a door was painful.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling in the finger tips all the way down arm pain in upper arm.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dysgraphia, Pain, Paraesthesia
Clinical narrative: After receiving 2nd Gardasil pt c/o body aching and tingling in her extremities. Symptoms so apparent that pt's writing is not the same and had difficulty typing. Took 800 mg of Advil with minimal relief. Pt states similar symptoms after 1st Gardasil 10/13/13. When she was then worked up for a pinched nerve all tests were normal.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Dysgraphia, Laboratory test normal, Pain, Paraesthesia
Clinical narrative: After receiving 2nd Gardasil pt c/o body aching and tingling in her extremities. Symptoms so apparent that pt's writing is not the same and had difficulty typing. Took 800 mg of Advil with minimal relief. Pt states similar symptoms after 1st Gardasil 10/13/13. When she was then worked up for a pinched nerve all tests were normal.
Age: 21.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Dyspnoea, Erythema, Flushing, Headache, Injection site erythema
Clinical narrative: Heat, redness, tenderness, firm at injection site. Flushed red face, complaints of shortness of breath, headache.
Age: 21.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Heat, redness, tenderness, firm at injection site. Flushed red face, complaints of shortness of breath, headache.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash with welts on chest and abdomen/trunk of body started within 12 hrs of receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: After vaccination pt. experienced high fever 102.5 and (L) upper arm was hot/swollen/red. Mom took to ER 10/19/13 dx - cellulitis meds - KEFLEX given. Pt. came to our office today for ER follow up 10/21/13 pt. to continue KEFLEX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chest pain, Injection site rash, Local swelling, Neck pain
Clinical narrative: Patient stated shortly after returning from pharmacy her arm began swelling and was very tender. By next AM  it was swollen to size of baseball and could not even wear jacket. Patient began having "fiery" pain on neck and chest and rash around injection site and on trunk. Ran temp of 100.3 until Sat PM but still has rash about 2 inches around injection site. Patient took Benadryl for rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: Patient stated shortly after returning from pharmacy her arm began swelling and was very tender. By next AM  it was swollen to size of baseball and could not even wear jacket. Patient began having "fiery" pain on neck and chest and rash around injection site and on trunk. Ran temp of 100.3 until Sat PM but still has rash about 2 inches around injection site. Patient took Benadryl for rash.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Crying, Diarrhoea, Pyrexia
Clinical narrative: 10/18 - Vaccines administer. 10/19 - Patient with fever 101.2 degrees - 103.6 degrees F and crying. 10/19 - Patient visited hospital ED. No further workup - treated symptomatically. 10/20 - F/up with patient - improving - fever reduced. 10/21 - Onset of diarrhea.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: ZOSTAVAX administered on Friday 10/11/2013. The following day pt reported a low grade fever, redness and swelling and pain at the injection site. Pt came into pharmacy on Tuesday 10/15/13 still with severe redness, pain and swelling at injection site. Referred to dr diagnosis -> allergic reaction to vaccine. Pt to continue naproxen and add diphenhydramine checked in with pt today much better but not completely recovered.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Laboratory test, Nausea
Clinical narrative: Severe nausea and upper abd pain.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Differential white blood cell count, Full blood count, Pain in extremity, Purulent discharge
Clinical narrative: L arm pain Friday. Vesicles Saturday. Puss drained Saturday-Sunday. Treated with clindamycin.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Testicular pain
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old son. On 09-MAY-1997 and 02-OCT-2013, the patient was vaccinated with the first and the second dose of VARIVAX (Merck), injection in the arm, (dose and strength were not reported). The concomitant therapy included MENACTRA was administered at the same time of dose 2. The consumer reported that within two hours of received both vaccines (on 02-OCT-2013), her son reported the sudden onset of severe testicular pain, occurred on both sides, but absent of swelling. The pain was described, "as if someone was squeezing them." His condition was treated with MOTRIN tablets and bedrest. Upon awaken the next morning (on 03-OCT-2013), the pain had subsided. The outcome of the event was recovered.  The patient sought medical attention through the way of make a phone call. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema
Clinical narrative: Patient complained of dizziness for about 24 hours after vaccination.  There was a red area around vaccination site about 1 to 1.5".
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right 5th finger has lateral numbness/tingling.  No pain or change in appearance, no temperature change from rest of hand.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitus at the site of the immunization, redness and warm to the touch.  Blood sugar also spiked to 405.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Feeling hot, Pain
Clinical narrative: Started feeling achy after shot, by 9PM started chilling with left arm pain. Was chilling so bad the bed was shaking. 12:30 AM on 10/10/13 quit shaking. 2:30 AM on 10/10/13 "felt warm" but did not take temp. Felt "achy in joints and drained of energy" upon waking 10/10/13. By 10/11/13 just had the achy Lt arm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Started feeling achy after shot, by 9PM started chilling with left arm pain. Was chilling so bad the bed was shaking. 12:30 AM on 10/10/13 quit shaking. 2:30 AM on 10/10/13 "felt warm" but did not take temp. Felt "achy in joints and drained of energy" upon waking 10/10/13. By 10/11/13 just had the achy Lt arm.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Eyelid function disorder, Fatigue, Glassy eyes, Oropharyngeal pain
Clinical narrative: Per patient description: "At 04:30 am I woke up and couldn't open my eyes and face and my eyes were swollen.  Applied cold compress.  At 6:30am the swelling was going down, eyes were still puffy and I was congested. Presently at 10:00 am I am still fatigued, my eyes are glassy but not swollen, my throat is sore and I'm congested".
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Per patient description: "At 04:30 am I woke up and couldn't open my eyes and face and my eyes were swollen.  Applied cold compress.  At 6:30am the swelling was going down, eyes were still puffy and I was congested. Presently at 10:00 am I am still fatigued, my eyes are glassy but not swollen, my throat is sore and I'm congested".
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Urticaria, Visual impairment
Clinical narrative: Associate became lightheaded and lost her balance.  B/P 135/105.  By the time the ambulance arrived she had hives to her chest, neck and forehead.  She was "seeing black spots".
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Lump at injection site, swelling, redness, itching, sore (all localized to injection site).
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness (approximately 2 inches in diameter) at injection site lasting 7 days after the injection. No pain.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Pain, Rhinorrhoea, Throat tightness
Clinical narrative: THROAT CLOSED UP, COUGHING NOSE RUNNING AND ACHED ALL OVER.
Age: 54.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: Night vaccine given patient started with fever. Took Aleve and fever went away. Next morning 10/16/2013 shingles shot site swollen and hot to touch. Single large vesicle formed at site. On 10/17/13 site started to become painful to touch, pain 7 out of 10. Site still painful to touch today but swelling has gone down and no longer warm to touch. No additional fever and no hard lump under skin. Patient called clinic today 10/21/2013 and advised to see PCM due to site still being painful and to call clinic back if could not see PCM in next 24 hours.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Oedema mouth, Swollen tongue
Clinical narrative: Patient states that he started with burning sensation in both eyes followed coughing and swelling of the mouth and tongue.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Body temperature increased, Computerised tomogram head normal, Confusional state, Dizziness, Encephalitis
Clinical narrative: Developed numbness in feet and legs a few hours after flumist vaccine. Low grade temp for one day (10/12/13).  On 10/13/13 had altered mental state,was confused and dizzy, couldn't bear weight and fell.  Admited to Hospital.  LP results consistent with aseptic meningitis/encephalitis.  CT of head showed no intracranial abnormality.  Mental status returned to normal and was discharged on 10/16/13.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Fall, Hypoaesthesia, Lumbar puncture abnormal, Meningitis aseptic, Mental status changes
Clinical narrative: Developed numbness in feet and legs a few hours after flumist vaccine. Low grade temp for one day (10/12/13).  On 10/13/13 had altered mental state,was confused and dizzy, couldn't bear weight and fell.  Admited to Hospital.  LP results consistent with aseptic meningitis/encephalitis.  CT of head showed no intracranial abnormality.  Mental status returned to normal and was discharged on 10/16/13.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Weight bearing difficulty
Clinical narrative: Developed numbness in feet and legs a few hours after flumist vaccine. Low grade temp for one day (10/12/13).  On 10/13/13 had altered mental state,was confused and dizzy, couldn't bear weight and fell.  Admited to Hospital.  LP results consistent with aseptic meningitis/encephalitis.  CT of head showed no intracranial abnormality.  Mental status returned to normal and was discharged on 10/16/13.
Age: 49.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Rash
Clinical narrative: Acute onset of rash and itching on trunk and neck last approx 60 hours.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Injected limb mobility decreased
Clinical narrative: About 2 hours after received vaccine, patient states she went to lift her left arm and was unable to. State has not been able to use left arm for daily activities for 2 weeks, since receiving vaccine. Denies and redness or swelling at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient visited pharmacy for a flu shot and stated that at an unspecified time in the past, she had received ZOSTAVAX injection (dose, route, lot number and expiration date not provided), at an unspecified location and from an unspecified provider, and on an unspecified date, she experienced post-vaccination rash that resembled shingles. The outcome of post vaccination rash resembled shingles was not reported. The relatedness between post-vaccination rash resembled shingles and ZOSTAVAX was not reported. Additionally, it has been reported that therapy with ZOSTAVAX was not reintroduced. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching and slight swelling at injection site.  Approximately 3 in diameter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 74 year old female patient. The patients pertinent medical history was unknown, the patient had no known allergies. On 05-OCT-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number J004270, expiry date 12-JUL-2014), subcutaneous in the back of right arm. Concomitant therapies included AFLURIA was given 2 weeks before ZOSTAVAX on an unspecified anatomical site. On 05-OCT-2013, the patient noticed some blood at the injection site of the right arm. The patient now had a red ring at the injection site of the right arm with a red streak going down her right arm. There was no treatment rendered for the events. The outcome of the reported events were not recovered. The patient sought medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with drug hypersensitivity to Neomycin. On 22-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose not provided), subcutaneous. On an unspecified date in 2013, after receiving ZOSTAVAX, the patient "felt a little sick". Patient reported to the pharmacist that this might be because she was allergic to Neomycin, which had manifested as contact dermatitis in the past. There was no treatment given for the adverse event. The outcome of felt a little sick was reported as recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of  unknown age. Information regarding the patient's pertinent medical history was not provided. On 08-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. Lot number, strength and dose were not reported. Information regarding concomitant medication was not provided. On 09-OCT-2013, the patient developed blisters. The patient sought medical attention, she saw the pharmacist. No treatment was given for the event. At the time of report, the patient was recovering from blisters. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Confusional state, Headache, Hypoaesthesia, Nervous system disorder, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medications were provided. On an unknown date after the vaccination the patient experienced "CNS problems". The patient developed numbness and tingling in hands, confusion and headache. No outcome was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. No medical history provided. On 17-OCT-2013 (also reported as 18-OCT-2013) the patient was vaccinated with expired ZOSTAVAX (vial, lot # 0467AE; expiration date 04-APR-2013) for vaccination. No adverse event was reported. No outcome was reported. Additional information in not expected.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 69 year old male patient. on 11-OCT-2011, when the patient was 67 years old, the patient was vaccinated with a dose of VARIVAX (dose, route and lot # not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist stated that a physician's office had administered a vaccine, unknown if the vaccine was VARIVAX or ZOSTAVAX. Patient would have been indicated for ZOSTAVAX not VARIVAX. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a Registered Nurse via Company Representative concerning a female patient of unknown age. The patient was not pregnant. On 12-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml intramuscular (dose and route were not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. According to the nurse, a patient developed an injection site reaction to ZOSTAVAX, which included itching, redness and severe pain after the ZOSTAVAX, was administered intramuscularly rather than subcutaneously on 12-OCT-2013. The patient sought medical attention by speaking with the nurse. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with PNEUMOVAX 23. On 10NOV2012, the patient experienced an adverse reaction (not further specified) to the PNEUMOVAX 23. The reporter stated Novartis as manufacturer but this is conflicting information. Treatment and outcome of the adverse event was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 64 year old female patient. The patient's drug reactions/allergies included PHENERGAN allergy, DEMEROL allergy, iodine allergy and sulfa (exact allergic reactions to all of these were unspecified). On 28-SEP-2013, the patient was vaccinated with PNEUMOVAX23 lot # J004332 (expiration date 26-SEP-20014) 0.5 ml, intramuscular. Concomitant therapies included FLUVIRIN given on the same day as PNEUMOVAX23 (which arm was unspecified). On 28-SEP-2013, the pharmacist reported that after the patient was administered PNEUMOVAX23, the patient developed redness and swelling at the injection site, and the patient's entire arm where she had PNEUMOVAX23 administered to was now red and swollen. On an unspecified date, the patient sought medical attention, the patient contacted the pharmacist. There was no treatment given for the adverse events. There were no labs diagnostics studies performed to the patient. At time of report, the patient had not recovered of the events. Additional information has been requested.