chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.36
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site nodule
Clinical narrative: Knot on RVL, noticed 11-09-12, by parent.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Shooting pain down her arm. Heaviness in her arm.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient said shot hurt immediately - thought pain would subside over several days never did went to MD on 11/5/2012 for physical - MD thought possible nerve damage - seeing neurologist on 11/16/12.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at site upper sore. Patient cannot lift her arm up.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Rash erythematous, Tenderness
Clinical narrative: (L) arm with swelling, tenderness and erythematous patch involving the lateral aspect of the arm.
Age: 60.0
Sex: F
Vaccine: FLU3, HEPAB
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Pt was given #3 dose of accelerated TWINRIX at 9AM at Co Dept PH. 11AM went to another location & was given influenza vaccine. Within short period c/o sore throat & slight headache.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient passed out about 5 minutes after receiving flu shot. We helped her to a chair - she was pale & sweating for a few mins. She sat there about 20 mins. Paramedics came to check her out but she said she was fine & declined.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Patient complained of numbness and tingling after receiving injection in left arm. Also decreased function and support of arm. Pain to lateral deltoid with radiating numbness and tingling to the fingers. Difficulty with lateral raising.
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: C/o mild soreness to injection site (Lt Del) on lifting arm. No swelling, increased warmth, redness, sensitivity to touch or fever.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching, redness, swelling bumpy about 1 hr after shot given. Patient states she wants to "Rip" her arm off it itches so bad.
Age: 10.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Crying, Irritability
Clinical narrative: "Fussiness, irritability, crying for over an hour" x 3 days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Joint pain, muscle pain, chills, sweats, fatigue, dizzy.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Joint pain, muscle pain, chills, sweats, fatigue, dizzy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Blood lead, Discomfort, Full blood count normal, Laboratory test normal, Scrotal oedema
Clinical narrative: Urticaria - 10/25 - minimal urticaria, ? scrotal discomfort advised use of OTC antihistamines. Pt seen in UC 10/26 US of scrotum showed edema - not orchitis or torsion. Labs drawn, no DM, CBC normal. Pt seen by Dr 10/30 scrotal swelling resolved, 3 hives left. No follow up needed unless recurs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria - 10/25 - minimal urticaria, ? scrotal discomfort advised use of OTC antihistamines. Pt seen in UC 10/26 US of scrotum showed edema - not orchitis or torsion. Labs drawn, no DM, CBC normal. Pt seen by Dr 10/30 scrotal swelling resolved, 3 hives left. No follow up needed unless recurs.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Oedema peripheral, Rash
Clinical narrative: Mom specifies that girl has rash around mouth after the administration of the vaccine. Left foot swollen.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain
Clinical narrative: Pain in left upper arm (injection in (L) upper arm) from 10/31/12 -> 11/3/12. Dull headache from 10/31/12 -> 11/4/12.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Seizure like phenomena
Clinical narrative: Patient was in office for well check-up. Had a fingerstick for CBC followed by 2 immunizations, GARDASIL and FLUZONE. Shortly after, patient experienced seizure-like movements observed by this nurse. Feet elevated above heart, supportive care given and pt. walked out of office independently with mother.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Myalgia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: 2 days after shot - muscle soreness, then 1 week after pain up side arm and from neck to ear with normal activities. Pain feels like pins and needles.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Reported myalgia the day following flu vaccination.
Age: 77.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old male patient. The patient's medical history included: difficulty sleeping and high blood pressure. The patient was vaccinated with 0.5 ml PNEUMOVAX 23 once in the deltoid region of his right arm on 25-OCT-2012. Lot number H010916; expiry date 15-FEB-2014. Earlier the same day the patient received a flu shot (not otherwise specified) in his left arm. A shingles vaccine (not specified) was administered one month before in 2012. Concomitantly the patient took AMBIEN, tramadol hydrochloride, aspirin (81 mg daily) and amlodipine besylate, LOTREL 5/20. On 25-OCT-2012 the patient experienced aching all over and his right arm was twice the normal size, really hot, and hurting. The patient was advised by the pharmacist to take BENADRYL and TYLENOL. No laboratory testing was performed. At time of the call the patient reported that the achiness was better, he was using an ice pack on his right arm. The patient reported that he could not lift his right arm above his shoulder without excruciating pain. The pharmacist was planning to notify the patient's physician regarding the events. The outcome of the events swollen right arm and pain while lifting his right arm were not provided. The relatedness for the events for PNEUNOMOVAX 23 was not provided. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain & redness at injection site. Symptom subsided 10/29/12.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema, & pain to (L) deltoid warm to touch, decreased ROM. Sx resolved 10/28-10/29.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt upper arm cellulitis (swelling, erythema, pain) took approximately 9d to resolve.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dry throat, Oropharyngeal pain, Pain, Rhinitis
Clinical narrative: Body aches all over, sore & dry throat, rhinitis. Felt better after 2 wks.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Myalgia
Clinical narrative: Reported felt ill w/ chills & myalgia the day after she was vaccinated w/ flu vaccine.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt received FLUZONE HD vaccine on 10/08/2012. Pt had tingling in the arm occur and as a result went to ER that night. It's been about more than a month and pt still tingling & numb.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Pt. experienced stiffness in the arm that I gave her the flu shot in and wasn't able to move it freely.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Throat tightness
Clinical narrative: 30 minutes after receiving vaccine, client said "I feel funny". I instructed him to remove shirt. No rash present. Client said he felt tightness in his throat I administered Epi 0.3 ml and called EMT's. Client treated and transported.
Age: 24.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Presyncope
Clinical narrative: At 1620 the client received both Tdap & Influenza vaccines. The client reporting having a fear of needles prior to administration. He denied adverse reaction to vaccine / medicine in his history. At 1630 the client became "dizzy lightheaded". He proceeded to sit on the floor. A near syncopal episode experienced 1635 VS: BP - 108/66; 1650 BP - 132/88: client stabilized; no treatment given; sips of water only. Instructed to perform deep breathing exercises.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient received FLUVIRIN on 9/14/12. Complained about muscle pain and visited her Dr on 11/13/12 because it was not going away.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dizziness, Dysphagia, Pharyngeal oedema
Clinical narrative: Vaccine received at approx 3 pm. At approx 8 pm patient report difficulty swallowing, like his throat was swelling. 20 min later he developed a cough. BENADRYL 25mg given and the cough cleared. Dizziness through next day.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Local reaction, Pruritus, Rash generalised
Clinical narrative: Pt had a local reaction with redness and itching 1 day after vaccine administration, 3 days after administration, pt broke out in a severe rash all over body with itching/pain at vaccine site (L) arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Pt had a local reaction with redness and itching 1 day after vaccine administration, 3 days after administration, pt broke out in a severe rash all over body with itching/pain at vaccine site (L) arm.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Abdominal discomfort, Discomfort, Dizziness, Headache, Pain
Clinical narrative: Headache, dizzy spells, GI upset. Tx: TYLENOL or MOTRIN q4 hours prn pain/discomfort; increase fluids.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Fatigue, Headache, Myalgia
Clinical narrative: 10-16-12 Evening had elevated temp up to 101 oral. Muscles and joints ached. Had 2 further incidents of temp 101. Continued muscle and joint aches. Headaches on daily basis. Progressive fatigue throughout day.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Injection site pain, Pain, Pain in extremity
Clinical narrative: Intermittent fever of 99.2-103 degrees for 12 days. Body aches and chills, especially leg pain. Pain in arm at site of injection - felt like a severe pinch that wouldn't go away.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Intermittent fever of 99.2-103 degrees for 12 days. Body aches and chills, especially leg pain. Pain in arm at site of injection - felt like a severe pinch that wouldn't go away.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Arm two times it size. High fever. Aches, very red. BENADRYL and aspirin.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Injection site erythema, Injection site pain, Oropharyngeal pain
Clinical narrative: Influenza vaccine recd 10-31-12. Began 11-2-12 w/ sore throat, loss of hearing (L) ear, redness & soreness at site of injection.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient reporting fever, chills, pain, redness, warmth, swelling at injection site. Will seek medical attention from physician.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Patient reporting fever, chills, pain, redness, warmth, swelling at injection site. Will seek medical attention from physician.
Age: 40.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Malaise, Pyrexia, Skin warm, Swelling
Clinical narrative: Red, (3-4 inches long 2 inches wide), feeling ill, swollen, a little bit warm no fever. Lasted 3-4 days took BENADRYL the next day & started feeling better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received KINRIX / Varicella in right arm, MMR in left arm, FLUMIST nasally. Right arm presented next day with redness, swelling, warmth. Referred to a doctor.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Oedema peripheral, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient complained of great fatigue 3 hours after receiving vaccine with sore left arm. Fatigue continued through night. (L) arm soreness persistent. Cannot sleep on left arm. Difficulty lifting (L) arm over head without pain. No relief with meloxicam, which she has for knee problems. Saw family doctor today - to see orthopedist for knee pain & also pain in (L) arm occurring after flu vaccines. (L) arm slightly puffy for 2 weeks after injection - using ice - not puffy now.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Pt states he is unable to lift arm. Sx since vaccine given. Referred patient to MD. This was reported today 11/13/12.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Patient was given FLUMIST on 11-5-12 started with (hives everywhere) was advised to give him BENADRYL and have him seen in urgent care with concerns per phone note on 11-7-12. They took patient to ED and he is doing much better now as of 11-07-12 1900 hrs.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: On Monday 29th pt stopped and stated her arm was sore. Suggested ice pack and BENADRYL if inflamed. Pt stopped by again on Nov 8 and was still having pain in arm.
Age: 0.25
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Evaluated patient had cellulitis on right thigh 6 cms oval had induration (L) thigh 1 cm oval induration warm compress / IM & PO antibiotics, mom stated the cellulitis is subsided & is feeling well.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of very sore arm the day after vaccination. Low mobility. She called it "dead arm." Improving about 10% per day. Pt consulted MD & was told he has seen this before w/ flu shot.
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Event may or may not be related as patient has as stated may noted illness. Patient described N/V after shot. Not sure if related but I wanted to report it regardless as I told patient just to be safe.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Blood test, Injection site erythema, Injection site streaking
Clinical narrative: Patient developed redness and streaking went to ER on 11/11/12 and was put on IV antibiotics as of today 11/13/12 patient was off of IV antibiotics and put on oral antibiotics. This was at injection site of PNEUMOVAX.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out about a minute after receiving flu vaccine she came back around within 2 minutes and stayed in our office for 15 minutes after.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out about 2 minutes after receiving flu shot she came out of it within a minute and stayed in our office for observation about 15 min.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt called shortly after receiving shot complaining of pain up and down her arm. Says she has never experienced this with a flu shot before. Pain was not localized. Followed up with pt later in the evening. She says her arm was much better, but had localized pain at injection site.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling, burning sensation at injection site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Oedema peripheral
Clinical narrative: Regional lymph nodes enlarged temporarily (& tender), (L) arm "swollen", "muscle aches". As of report date lymph nodes are no longer tender, one in the posterior cervical chain is enlarged. No other symptoms remain.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Eyelid oedema
Clinical narrative: Pt returned to Clinic in late afternoon with c/o possible reaction to FLU SHOT given earlier today. Pt reports symptoms as eyes being a little itchy and puffy. The Vaccine Information Statement reports red or itchy eyes as a mild problem. Diphenhydramine.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out 2 minutes after receiving flu shot. She was out for 20-30 seconds. She woke up and was fine without any problems.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Diarrhoea, Nausea, Oral herpes, Pain
Clinical narrative: Fever 101. 2. Chills. Body aches. Diarrhea. Nausea. Cold sores on mouth.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever 101. 2. Chills. Body aches. Diarrhea. Nausea. Cold sores on mouth.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, ring around injection site, warm to touch, swelling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Developed a hard lump (approx 4 inches around) at the injection site, red, warm, and pain extends up to the shoulder, pt took BENADRYL & iced the area, pain is better today & rash also, but still hurts & is red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed a hard lump (approx 4 inches around) at the injection site, red, warm, and pain extends up to the shoulder, pt took BENADRYL & iced the area, pain is better today & rash also, but still hurts & is red.
Age: 69.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Joint swelling, Oedema peripheral
Clinical narrative: (R) wrist and hand swelled after PNEUMOVAX in (R) delt. and TDaP in (L) on 11/8/12. Still swollen but improving on 11/12/12.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: HPV #2 administered in left upper arm. Provider was called to room immediately after vaccine administration due to syncopal episode. Pt placed in supine position and vitals carefully monitored. Patient recovered fully and was discharged home.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient was seen 2 days after vaccines at the after hours care for children, fever max 104 degrees Axillary.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling of upper - (R) arm, redness, pruritus, no fever, no tenderness, 11/7/2012 - 11/12/2012, no treatment, resolved.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Body temperature increased, Diarrhoea, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Evening of 11-11-12: fatigue, body aches; early A.M. 11-12-12: GI sxs 15-20 episodes of diarrhea and 1 x emesis Temp: 100.2 - 100.7. Myalgias persisted through 11-13-12 P.M. as well as headache; pushed fluids took TYLENOL - able to work 11-13-12.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Myalgia, Pain, Vomiting
Clinical narrative: Evening of 11-11-12: fatigue, body aches; early A.M. 11-12-12: GI sxs 15-20 episodes of diarrhea and 1 x emesis Temp: 100.2 - 100.7. Myalgias persisted through 11-13-12 P.M. as well as headache; pushed fluids took TYLENOL - able to work 11-13-12.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness and warmth/swelling on inside arm that vaccine was given. CLARITIN 10 mg daily x 7 days and monitor.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction
Clinical narrative: Large local reaction on arm, 10 cm x 3 cm area of erythema.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Outbreak of shingles 10/8/12 left axilla, approximately cluster ten blisters, physician visit 10/9/12,, rx valcyclovir HCL 1 gram 1 tab BID x 5 days - still fading.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Paraesthesia, Tenderness
Clinical narrative: Symptoms (L) arm started 8:00 am 11/6/12 - Following varicella imm. 11/5/12 in afternoon. Client reports extreme tenderness (L) arm from shoulder to fingertips (fingers "tingly"). Reports no fever, but (L) arm exhibits area of erythema 50 mm x 35 mm on back of arm at site of injection (subcu).
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Arm swelling & pain. No infection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling, Rash
Clinical narrative: Pain, swelling, bruising on arm at site of vaccine administration. Pt. also developed rash around neck & across chest.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Area (R) upper arm - red, painful, edematous since 11/3/12 - Rx'ed with cool compresses, watch for signs of infection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Paraesthesia oral, Sneezing
Clinical narrative: Vaccine administered at 11:20. At 12:15 patient called and felt chest tightening. Could not stop sneezing, tongue tingling.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Got dizzy, very lightheaded, collapsed over floor, unresponsive for a minute then revived on his own, felt nauseous.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Reported the onset of scattered 2-4mm papulovesicular lesions on extensor elbows, extensor forearms, and palmer surface of hands with an onset 17 days post vaccination with SPV on 14 May 12. Described as itchy bumps.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Localized allergic reaction and cellulitis.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Acanthosis, Biopsy skin abnormal, Eczema, Hyperkeratosis, Lymphocytic infiltration
Clinical narrative: Onset of pruritic papules approx 15 day post vaccination with SPV. Few papulovesicles, 2-4 mm in size, on the dorsal hands overlying the (R) 2nd and 3 MCP's, few also about PIP of (R) hand; fewer similar appearing lesions are also scattered in a similar distribution about the (L) hand.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Neurodermatitis, Papule, Parakeratosis, Pruritus, Rash
Clinical narrative: Onset of pruritic papules approx 15 day post vaccination with SPV. Few papulovesicles, 2-4 mm in size, on the dorsal hands overlying the (R) 2nd and 3 MCP's, few also about PIP of (R) hand; fewer similar appearing lesions are also scattered in a similar distribution about the (L) hand.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Rash papular, Skin lesion
Clinical narrative: Onset of pruritic papules approx 15 day post vaccination with SPV. Few papulovesicles, 2-4 mm in size, on the dorsal hands overlying the (R) 2nd and 3 MCP's, few also about PIP of (R) hand; fewer similar appearing lesions are also scattered in a similar distribution about the (L) hand.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling
Clinical narrative: Reports that he developed lip swelling after receiving the Tdap injection 3 days ago. No difficulty with breathing. The lip swelling has now improved. Presents for further eval. PE shows mild swelling of the lower lip. Otherwise all other systems are normal. He is currently in no distress and is able to breathe normally. May be related to the vaccine he received on 10/26. Will treat with a course of BENADRYL.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills
Clinical narrative: Patient reports he experienced severe chills on the night of 11/12/2012 (the day of vaccine administration) b/w hours of 9:30PM-11:00PM period. He states, he had 3 episodes of chills, that resolved when he covered himself. Pt also took TYLENOL, no symptoms in the morning.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: Patient had extreme sweating episodes for 1 week after administration. Patient did say that he had received steroid shot the next morning before. ZOSTAVAX but had not told us or checked the box indicating he had received steroids.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The physician reported that GARDASIL carton was missing a vial upon opening a carton and patient missed the dose due to his quality issue. The office did not have any extra GARDASIL to administer a dose for patient. No adverse effects reported. PQC filed. Patient missed dose due to quality issue is not related to GARDASIL. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported) on 27-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 17-OCT-2012 the patient got his second dose. No adverse reaction reported. The reporter was connected with the support line for assistance. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Nausea, Pain in extremity, Rash macular, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her 22 years old daughter who was not pregnant with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intramuscularly with first and second doses of 0.5 ml GARDASIL (Lot number reported as H013831, expiration date 06-MAR-2015) in June 2012 and on 07-NOV-2012 respectively. There was no concomitant medication. The patient experienced "red blotches radiating from the injection site to the wrist" within one half hour after administration of the second dose of GARDASIL on 07-NOV-2012. The arm felt "heavy and painful" and the patient also experienced nausea. The patient called unspecified physician's office for medical attention. No laboratory studies performed. The symptoms resolved in 5 hours without requiring treatment. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. In 2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). On 05-NOV-2012, the patient was back in the office for the second dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Malaise, Pyrexia, Rash generalised
Clinical narrative: Fever, malaise, rash that started from the belly & spread all over her body. Treated w/ BENADRYL & TYLENOL as needed.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash generalised
Clinical narrative: Shingles rash began less than 24 hours after vaccine. Area was (L) upper chest, (L) shoulder, (L) scapular area and (L) neck. Very painful. It has taken 1 month for rash to subside. Area is still painful.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: HPV #3 adm yesterday. Mother reports today pt has headache, some nausea & sore arm. Mother insists on reporting.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 3 patients of unknown age. The patients were vaccinated with improperly stored VAQTA (lot# reported as 0273AE; expired date: 06-DEC-2014) on either 05-NOV-2012 or 06-NOV-2012. (The physician was not sure of the exact date of administration). No other co-suspects were reported. No concomitant medications were reported. The VAQTA was exposed to 50F for 120 hours. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with VARIVAX (merck). No other co-suspects were reported. No concomitant medications were reported. A medical assistant called and stated a person from the state told their office not to use VARIVAX since there were no temperature logs for AUG-2012 and SEP-2012. Medical assistant is not sure whether the temperature was out of range since there is no temperature logs. The healthcare worker reported that the patient was administered VARIVAX, then later finding out that the stability of that product was not longer any good. No adverse events were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Dizziness, Headache, Laboratory test, Nasal congestion
Clinical narrative: Initial report received from a healthcare professional on 08 October 2012. A 21-year-old female patient received MENACTRA (batch number: U4395AA) intramuscularly in the left deltoid on 27 September 2012. Medical history was none and concomitant medications were not reported. The patient received previous dose of MENACTRA vaccine in 2008. On 28 September 2012, the patient presented with headache, dizziness, nasal congestion, sore throat, nausea and back pain. It was reported that the patient was evaluated by physician at student HC. The patient was advised to take Ibuprofen for headache and back pain. On unspecified date lab work was done and neuro exam was normal. On 04 October 2012, the symptoms were not resolved. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Neurological examination normal, Oropharyngeal pain
Clinical narrative: Initial report received from a healthcare professional on 08 October 2012. A 21-year-old female patient received MENACTRA (batch number: U4395AA) intramuscularly in the left deltoid on 27 September 2012. Medical history was none and concomitant medications were not reported. The patient received previous dose of MENACTRA vaccine in 2008. On 28 September 2012, the patient presented with headache, dizziness, nasal congestion, sore throat, nausea and back pain. It was reported that the patient was evaluated by physician at student HC. The patient was advised to take Ibuprofen for headache and back pain. On unspecified date lab work was done and neuro exam was normal. On 04 October 2012, the symptoms were not resolved. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning 3 patients of unknown age and gender. The nurse reported that on 31-OCT-2012, the patients were vaccinated with M-M-R II (lot# 1506AA/ Exp. Date: 23-SEP-2013) (dose and route not reported) that was improperly stored that was exposed to 40 F degree for 7 hours. No adverse symptoms were reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. The patient was vaccinated with VAQTA on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received a dose of VAQTA which was exposed to 22.6 Fahrenheit for 13 hours. No adverse effect reported. No further information is available. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a 72 years old female patient concerning to her. The patient's medical history included low thyroid. On 17-JUL-2012, the patient was vaccinated with ZOSTAVAX about 3 inches from her armpit on the underside of her left arm (dose, route and lot not reported0. No other co-suspects were reported. Concomitant medication included "thyroid medication". On 17-JUL-2012, the patient had experienced swelling and redness at the injection site. The area of reaction varies in size from the size of a quarter to the size of a penny. No treatment information was reported. The patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) refers to a patient of unknown age and gender. On 06-NOV-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 671663/1159AA, expiration date 18-OCT-2012) dose and route not reported. No concomitant medications were reported. No adverse effect reported. No further information is available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Certified Pharmacy Tech refers to a 45 years old female patient. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (Merck). No lot# and route reported. No adverse effect reported. It was unspecified if the patient sought medical attention. 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 pharmacist refers to a patient of unknown age. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # (671022/0745AA, expiry date:18-AUG-2012) that had expired on 09-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with LIQUID PEDVAXHIB (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, PNEUMOVAX 23, VAQTA and RECOMBIVAX HB that were exposed to temperatures above 46F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1210USA007111, 1211USA001302, 1211USA001296 and 1211USA001297. 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 medical assistant refers to a patient of unknown age. On 05-NOV-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 671075/1197AA, exp. date: 25-OCT-2012). No adverse symptoms reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 98.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site abscess sterile, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Severe rash, infection, pain from July 2012 - October 2012.
Age: 98.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Pain, Rash
Clinical narrative: Severe rash, infection, pain from July 2012 - October 2012.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pruritus, Injection site swelling, Muscle tightness
Clinical narrative: Swelling in the arm that moved across shoulder & neck area. Hoarseness & asthma. Advised to take BENADRYL & XOPENEX.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthma, Dysphonia, Local swelling, Oedema peripheral
Clinical narrative: Swelling in the arm that moved across shoulder & neck area. Hoarseness & asthma. Advised to take BENADRYL & XOPENEX.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an other health professional concerning a 69 year old female patient. On 25-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not provided) (Lot # and expiration date were not provided). On 26-OCT-2012, the patient developed injection site swelled to quarter size and sore. Patient was advised to take BENADRYL as directed and to apply cold compresses. At the time of the report, the patient's outcome of injection site swelled to quarter size and injection site sore was unknown. The relatedness for injection site swelled to quarter size and injection site sore was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an other health professional concerning a 69 year old female patient. On 25-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not provided) (Lot # and expiration date were not provided). On 26-OCT-2012, the patient developed injection site swelled to quarter size and sore. Patient was advised to take BENADRYL as directed and to apply cold compresses. At the time of the report, the patient's outcome of injection site swelled to quarter size and injection site sore was unknown. The relatedness for injection site swelled to quarter size and injection site sore was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Weight bearing difficulty
Clinical narrative: This spontaneous report was received from a 65 years old male patient with no drug reaction/allergy. The patient's medical history included kidney stones and depression, and an outbreak of shingles in 1986. The patient was vaccinated with ZOSTAVAX injection on upper left arm on 30-OCT-2012. Lot# was reported as H013020 with expiration date on 09-OCT-2013. Concomitant medications included hydrochlorothiazide and LEXAPRO. On 30-OCT-2012 on the first day of injection, the patient experienced oblong patch of redness and itching. This reaction had subsided. On 04-NOV-2012, a few days after injection was given, the patient started to feel an intense nerve pain on one side of his right leg that was so painful to even move he refers to "paralysis". The patient had an outbreak of shingles back in 1986 mid torso right side going towards the back. The patient said the feeling he was experiencing now felt the same as when he had shingles back in 1986. Gabapentin 3 times daily 300mg was given as treatment. No lab test was done. The outcome of patient was unknown. The patient sought unspecified medical attention. Upon internal review, paralysis was considered to be a medical significant event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Neuralgia, Pain, Paralysis, Pruritus
Clinical narrative: This spontaneous report was received from a 65 years old male patient with no drug reaction/allergy. The patient's medical history included kidney stones and depression, and an outbreak of shingles in 1986. The patient was vaccinated with ZOSTAVAX injection on upper left arm on 30-OCT-2012. Lot# was reported as H013020 with expiration date on 09-OCT-2013. Concomitant medications included hydrochlorothiazide and LEXAPRO. On 30-OCT-2012 on the first day of injection, the patient experienced oblong patch of redness and itching. This reaction had subsided. On 04-NOV-2012, a few days after injection was given, the patient started to feel an intense nerve pain on one side of his right leg that was so painful to even move he refers to "paralysis". The patient had an outbreak of shingles back in 1986 mid torso right side going towards the back. The patient said the feeling he was experiencing now felt the same as when he had shingles back in 1986. Gabapentin 3 times daily 300mg was given as treatment. No lab test was done. The outcome of patient was unknown. The patient sought unspecified medical attention. Upon internal review, paralysis was considered to be a medical significant event. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Computerised tomogram, Gait disturbance, Muscle contractions involuntary, Pneumonia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 05-Nov-2012) concerns an 83-year-old female patient, who had no pertinent medical history or drug allergy. Two-three years ago the patient received PNEUMOVAX 23 at a dose of 0.5 mL IM (intramuscularly) for routine vaccination. The patient also had possibly received flu vaccination concurrently. On 30-May-2012 the patient developed bilateral pneumonia. CAT (Computer Axial Tomography) scan was performed. The patient sought medical attention and was treated with LEVAQUIN which 'sucked up her muscles' to the point that she could hardly walk. Her pneumonia improved. The event outcome was recovered. Reporter's comment: On 05-Nov-2012 the reporter considered event to be serious as it resulted in significant disability or incapacity.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gait disturbance
Clinical narrative: (Ache in arm), chills, fever near 100 degrees all night, needed to urinate 3 times, became faint and couldn't walk alone.  In AM needed fluids and still felt faint. Very weak all day.  Took ibuprofen, fever went down, still weak and tired.  Better 11/09.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pollakiuria, Pyrexia, Syncope
Clinical narrative: (Ache in arm), chills, fever near 100 degrees all night, needed to urinate 3 times, became faint and couldn't walk alone.  In AM needed fluids and still felt faint. Very weak all day.  Took ibuprofen, fever went down, still weak and tired.  Better 11/09.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Hypersomnia, Immediate post-injection reaction, Malaise
Clinical narrative: Felt nauseated immediately after shot, then: Piercing headache, chills, fever, three days, little better, then hit again with headache, chills.  Just felt really, really sick. . . slept a lot.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Felt nauseated immediately after shot, then: Piercing headache, chills, fever, three days, little better, then hit again with headache, chills.  Just felt really, really sick. . . slept a lot.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Bone pain, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Unusually high pain at time of shot. Later pain at shot location. Felt like pain in the bone. Later I felt strong pain in muscle of left shoulder up to left side of neck. Only feel pain when sitting or standing. Laying down, I rarely feel the pain. I've tried Vicks vapo rub and Advil. That lessens the pain a little. A week later there's no lessening of the pain.
Age: 9.0
Sex: F
Vaccine: HPV4, PPV, FLU3, HPV4, PPV, FLU3, HPV4, PPV
Symptoms: Lumbar puncture abnormal, Meningitis, Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 years old female patient with pertinent history of hay fever and possibly ZITHROMAX reaction/allergy. The patient was vaccinated with first dose (lot # :671994/1537AA, Exp date 21-JUN-2014) and second dose (lot # :671994/1537AA, Exp date 21-JUN-2014) of GARDASIL on 20-APR-2012 and 02-JUL-2012 respectively. The patient received her third dose of GARDASIL (lot # :672652/0022AE, Exp date 28-SEP-2014) and a first dose of PNEUMOVAX 23 (671038/0811AA, Exp date 15-MAR-2013) on 06-NOV-2012, concomitant medications included: loratadine (manufacture unknown), then the patient developed fever within 24 hours of receiving vaccines on 06-NOV-2012 and went to ER. After series of tests, it was noted that her white blood cell count was elevated and spinal tap was performed and she was diagnosed with meningitis. Patient was admitted to Medical Center on 08-NOV-2012. Patient was treated with IV antibiotic (name unspecified) and her current condition was listed as "in the hospital but stable". The outcome of meningitis was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4, PPV, FLU3, HPV4, PPV, FLU3, HPV4, PPV
Symptoms: Abdominal pain, Blood culture negative, Body temperature increased, C-reactive protein increased, CSF culture negative
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 years old female patient with pertinent history of hay fever and possibly ZITHROMAX reaction/allergy. The patient was vaccinated with first dose (lot # :671994/1537AA, Exp date 21-JUN-2014) and second dose (lot # :671994/1537AA, Exp date 21-JUN-2014) of GARDASIL on 20-APR-2012 and 02-JUL-2012 respectively. The patient received her third dose of GARDASIL (lot # :672652/0022AE, Exp date 28-SEP-2014) and a first dose of PNEUMOVAX 23 (671038/0811AA, Exp date 15-MAR-2013) on 06-NOV-2012, concomitant medications included: loratadine (manufacture unknown), then the patient developed fever within 24 hours of receiving vaccines on 06-NOV-2012 and went to ER. After series of tests, it was noted that her white blood cell count was elevated and spinal tap was performed and she was diagnosed with meningitis. Patient was admitted to Medical Center on 08-NOV-2012. Patient was treated with IV antibiotic (name unspecified) and her current condition was listed as "in the hospital but stable". The outcome of meningitis was unknown. Additional information has been requested.