chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Complement factor normal, Cytogenetic analysis abnormal
Clinical narrative: Reaction occurs since 6 months of age: Parents presented with their 2 year old daughter to discuss concerns about recurrent nodules to bilateral legs following routine vaccinations and ROCEPHIN. They advised she has a history of developing large nodules to all injection sites on bilateral thighs/hips since receipt of 6 month old vaccinations. Nodules will form immediately and increase in size over the next few weeks or can begin a week later and grow. Nodules are described as firm, non-tender, non red, non itchy from pea size to oval shaped1x2x5 cm shaped. Warm baths/heat to area's does help resolve the reaction for some nodules while others persist for weeks. She has has 2-3 nodules develop pimple like white heads that popped with clear drainage. One area to left upper outer thigh did turn red and drained puss resolving with use of antibiotics. Mom advised she has noted nodules in areas not vaccinated at. Mom advised she had no fevers, fussiness or other systemic reactions other than the site reactions following vaccinations. Parents advise they have spoken with several other providers on this issue before referred to Agency. Symptoms: Local swelling, mass &lump,head(R220). HCP notes: 17 month old F who has developed subcutaneous nodules to both thigh after receiving vaccines. Mother states that the nodules do not appear to be painful. Denies developing nodule in areas where she did not receive vaccine. She got her 15 month shots since last seeing me and has a small nodule to the area with no overlying reds or increased warmth to touch. Reviews of her lab work showed a low IgA level with a normal IgG and IgM. Labs to evaluate complement system (IgA/IgG/IgM, AH50, ANA, CH50, Vit D, CBC, Chem panel) were within normal range. DHR test was not c/w Chronic Granulomatous disease. She had an order place for an ultrasound but has not had that done as of yet. 2/23/2016 US thigh: Impression: Findings as above most consistent with post injection hematomas. No skin induration or discomfort to specifically suggest a superimposed infection. Subcutaneous masses to anterior right and left thighs.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Immediate post-injection reaction, Injection site discharge, Injection site erythema, Injection site haematoma, Injection site induration
Clinical narrative: Reaction occurs since 6 months of age: Parents presented with their 2 year old daughter to discuss concerns about recurrent nodules to bilateral legs following routine vaccinations and ROCEPHIN. They advised she has a history of developing large nodules to all injection sites on bilateral thighs/hips since receipt of 6 month old vaccinations. Nodules will form immediately and increase in size over the next few weeks or can begin a week later and grow. Nodules are described as firm, non-tender, non red, non itchy from pea size to oval shaped1x2x5 cm shaped. Warm baths/heat to area's does help resolve the reaction for some nodules while others persist for weeks. She has has 2-3 nodules develop pimple like white heads that popped with clear drainage. One area to left upper outer thigh did turn red and drained puss resolving with use of antibiotics. Mom advised she has noted nodules in areas not vaccinated at. Mom advised she had no fevers, fussiness or other systemic reactions other than the site reactions following vaccinations. Parents advise they have spoken with several other providers on this issue before referred to Agency. Symptoms: Local swelling, mass &lump,head(R220). HCP notes: 17 month old F who has developed subcutaneous nodules to both thigh after receiving vaccines. Mother states that the nodules do not appear to be painful. Denies developing nodule in areas where she did not receive vaccine. She got her 15 month shots since last seeing me and has a small nodule to the area with no overlying reds or increased warmth to touch. Reviews of her lab work showed a low IgA level with a normal IgG and IgM. Labs to evaluate complement system (IgA/IgG/IgM, AH50, ANA, CH50, Vit D, CBC, Chem panel) were within normal range. DHR test was not c/w Chronic Granulomatous disease. She had an order place for an ultrasound but has not had that done as of yet. 2/23/2016 US thigh: Impression: Findings as above most consistent with post injection hematomas. No skin induration or discomfort to specifically suggest a superimposed infection. Subcutaneous masses to anterior right and left thighs.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule, Injection site pustule, Laboratory test normal, Local swelling, Mass
Clinical narrative: Reaction occurs since 6 months of age: Parents presented with their 2 year old daughter to discuss concerns about recurrent nodules to bilateral legs following routine vaccinations and ROCEPHIN. They advised she has a history of developing large nodules to all injection sites on bilateral thighs/hips since receipt of 6 month old vaccinations. Nodules will form immediately and increase in size over the next few weeks or can begin a week later and grow. Nodules are described as firm, non-tender, non red, non itchy from pea size to oval shaped1x2x5 cm shaped. Warm baths/heat to area's does help resolve the reaction for some nodules while others persist for weeks. She has has 2-3 nodules develop pimple like white heads that popped with clear drainage. One area to left upper outer thigh did turn red and drained puss resolving with use of antibiotics. Mom advised she has noted nodules in areas not vaccinated at. Mom advised she had no fevers, fussiness or other systemic reactions other than the site reactions following vaccinations. Parents advise they have spoken with several other providers on this issue before referred to Agency. Symptoms: Local swelling, mass &lump,head(R220). HCP notes: 17 month old F who has developed subcutaneous nodules to both thigh after receiving vaccines. Mother states that the nodules do not appear to be painful. Denies developing nodule in areas where she did not receive vaccine. She got her 15 month shots since last seeing me and has a small nodule to the area with no overlying reds or increased warmth to touch. Reviews of her lab work showed a low IgA level with a normal IgG and IgM. Labs to evaluate complement system (IgA/IgG/IgM, AH50, ANA, CH50, Vit D, CBC, Chem panel) were within normal range. DHR test was not c/w Chronic Granulomatous disease. She had an order place for an ultrasound but has not had that done as of yet. 2/23/2016 US thigh: Impression: Findings as above most consistent with post injection hematomas. No skin induration or discomfort to specifically suggest a superimposed infection. Subcutaneous masses to anterior right and left thighs.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Ultrasound scan abnormal, Velo-cardio-facial syndrome
Clinical narrative: Reaction occurs since 6 months of age: Parents presented with their 2 year old daughter to discuss concerns about recurrent nodules to bilateral legs following routine vaccinations and ROCEPHIN. They advised she has a history of developing large nodules to all injection sites on bilateral thighs/hips since receipt of 6 month old vaccinations. Nodules will form immediately and increase in size over the next few weeks or can begin a week later and grow. Nodules are described as firm, non-tender, non red, non itchy from pea size to oval shaped1x2x5 cm shaped. Warm baths/heat to area's does help resolve the reaction for some nodules while others persist for weeks. She has has 2-3 nodules develop pimple like white heads that popped with clear drainage. One area to left upper outer thigh did turn red and drained puss resolving with use of antibiotics. Mom advised she has noted nodules in areas not vaccinated at. Mom advised she had no fevers, fussiness or other systemic reactions other than the site reactions following vaccinations. Parents advise they have spoken with several other providers on this issue before referred to Agency. Symptoms: Local swelling, mass &lump,head(R220). HCP notes: 17 month old F who has developed subcutaneous nodules to both thigh after receiving vaccines. Mother states that the nodules do not appear to be painful. Denies developing nodule in areas where she did not receive vaccine. She got her 15 month shots since last seeing me and has a small nodule to the area with no overlying reds or increased warmth to touch. Reviews of her lab work showed a low IgA level with a normal IgG and IgM. Labs to evaluate complement system (IgA/IgG/IgM, AH50, ANA, CH50, Vit D, CBC, Chem panel) were within normal range. DHR test was not c/w Chronic Granulomatous disease. She had an order place for an ultrasound but has not had that done as of yet. 2/23/2016 US thigh: Impression: Findings as above most consistent with post injection hematomas. No skin induration or discomfort to specifically suggest a superimposed infection. Subcutaneous masses to anterior right and left thighs.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: High fever, rash, joint pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm at injection site.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Dermatitis atopic, Injection site erythema, Rash
Clinical narrative: Patient had redness around vaccination site for first 24hrs, this self-resolved w/o intervention. 40-48 hrs after vaccination he erupted in flares of atopic dermatitis in various locations on lower extremities. Rashes have continued erupting and are now on abdomen, pelvis, groin, face/neck, wrists. BENADRYL, ALLEGRA, CLARITIN, Prednisone. Allergy testing to be done. Rash still present on 5/30/17.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Paraesthesia, Peripheral swelling
Clinical narrative: Immunization (TDaP) given approximately 10:30am. Patient returned approximately 12:45pm with "stated" Right arm swollen to fingertips per stated by patient: Unable to lift arm and tingling. This nurse called by staff and advised to go to ER.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: On 5/19/2017 Patient went to urgent care for redness, swelling and pain left upper arm. Had fever for 48 hrs. Patient had a 4 cm in diameter area of induration, erythema, warmth and tenderness - no drainage. Patient required - Clindamycin and AUGMENTIN antibiotics.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: On 5/19/2017 Patient went to urgent care for redness, swelling and pain left upper arm. Had fever for 48 hrs. Patient had a 4 cm in diameter area of induration, erythema, warmth and tenderness - no drainage. Patient required - Clindamycin and AUGMENTIN antibiotics.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: Patient developed Left arm weakness and limited arm rotation.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Pain down arm on elbow. Pain of feel like something.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Soft tissue mass
Clinical narrative: 7 1/2 x 8 1/2 cm soft tissue mass at injection site LT upper arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patients arm (area of injection) swelled up, became red and itchy and painful.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: 3 hours after receiving PNEUMOVAX, patient noted her left arm (site of injection) was "knotty" and sore and she could not lay on it. The next morning the knot has gone but soreness remained. Patient denied redness, fainting, trouble breathing or any other issues. Patient denied any reaction to a previous shot including PREVNAR 1 year ago.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Chest pain, Cough, Pharyngeal oedema, Pruritus, Wheezing
Clinical narrative: 05-25-2017 at 10:30 AM: Received KINRIX IM in (R) VL and PROQUAD (R) thigh. Patient left office. Returned at 11:30 C/O swollen throat, itching, cough and chest hurting with wheezing. BENADRYL PO given and EPI PEN JR given IM.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Head discomfort, Headache, Syncope
Clinical narrative: Syncope, Headache. Faint within 10 min. of vaccine. "Pressure" in head day of vaccination and continued on day following (reported).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chickenpox S/P vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 2 vaccines place one on each arm on 6-6-17. Mom called office concerned that left arm was swollen and red to touch - was advised by office to mark area and apply BENADRYL cream on 6-7-17 - if no better call back for appt. Appt. on 6-8-17 (8 cm length, 12 cm width).
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema
Clinical narrative: Induration, localized erythema, edema.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Musculoskeletal pain
Clinical narrative: Musculoskeletal pain. No redness at the site.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: 2 hours after shot administered pt C/O fever, chills and headache. She was jut mildly sore after first vaccine. Next morning fever/headache gone. Still C/O body aches.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 6-7 AM woke up red area left leg size of lemon, 3 pm called to be seen. 4:15 - size of cantaloupe.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, redness and swelling in L arm where vaccine was administered.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Pt. states pain at injection site L Deltoid 5/30/17 PM. Thru out day 5/31/17 pain and burning increased. Redness stretched from outer deltoid area inside arm down to elbow. Pt. used ice on sites. 6/1/17 AM pt. presented at pharmacy we sent her to Dr. Prescribed MEDROL DP and clindamycin.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling and redness at the site. Positive induration noted centrally. Nontender to palpation.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Pt. had a generalized tonic clonic seizure x 6 minutes associated with fever.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt went to ER on 6/6/17 at 9:26 pm with complaints of redness and swelling of right upper arm. Diagnosed with cellulitis of right upper arm. Given Cephalexin 500 mg, 4 times a day for 7 days.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Three inch diameter swelling, erythema and pain surrounding injection site x 1 week, resembling arthus type reaction.
Age: 0.5
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Conjunctivitis, Cough, Drug administered to patient of inappropriate age, Erythema, Irritability
Clinical narrative: On 5/12/17 patient accidently received MMRV and Hep A vaccines (usually given at 12 months). Mistake was made by nurse. Eight days later more crabby, lethargic and T 99.9 Axillary. Developed cough, not sleeping well, irritable. Ten days after the vaccines, fever resolved. Developed conjunctivitis and nasal congestion. Had a couple red swollen spots on her body. Still irritable. Sx's improved by 5/24/17.
Age: 0.5
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Lethargy, Nasal congestion, Poor quality sleep, Pyrexia, Swelling
Clinical narrative: On 5/12/17 patient accidently received MMRV and Hep A vaccines (usually given at 12 months). Mistake was made by nurse. Eight days later more crabby, lethargic and T 99.9 Axillary. Developed cough, not sleeping well, irritable. Ten days after the vaccines, fever resolved. Developed conjunctivitis and nasal congestion. Had a couple red swollen spots on her body. Still irritable. Sx's improved by 5/24/17.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states pain, swelling, hot to touch around area of injection. Tx BENADRYL as needed.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Muscle swelling, Myalgia
Clinical narrative: Swollen and painful deltoid muscle (expected). On next morning redness developed - biceps muscle to elbow. Nurse noticed it and thought it was cellulitis. Went to hospital Urgent Care Center. Received intramuscular antibiotic and RX for cephalexin 500 mg for 10 days.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: MMR last 5/20 then see rashes red and raised on chest, abdomen, back C/O itchiness 5/24. Started BENADRYL 25 mg daily on 5/25 hydrocortisone 1% cream twice a day. Increase to steroid cream and added ZYRTEC.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: MA realized after the patient left that the immunization had expired on 4/15/17. The patient did not have any reactions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Received PROQUAD and KINRIX on 5/23/17 in (R) thigh. Now with 8 cm x 16 cm area with non pitting edema. 0.5 cm x 1 cm area of erythema lateral to that also without fluctuance or tenderness. No fever, chills, nausea or pain. Both reactions in (R) thigh. (+) redness and swelling.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Neuralgia, Sleep disorder
Clinical narrative: Rt. arm immediate pain with shot, still feel where it was given. 5 wks P.T. arm is not what it was before shot. Pain is like nerve pain. Cannot sleep Rt. side.
Age: 59.0
Sex: M
Vaccine: HEP, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Swelling
Clinical narrative: Pt received PREVNAR 13 on 5/16/17 in the left deltoid 5 days later developed redness over the injection site, 7 days since the vaccination the redness spreaded over (L) upper arm, swelling increased, no pain or itching.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: One wk after vaccine, developed a 1/2 dollar size rash at injection site, reported a little itchy. MD prescribed Abx, pt unable to take BENADRYL and rash spread down to elbow one day later. By 5/13/17 she said rash is almost gone.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Child was evaluated today - Well child exam and mom reports reaction to Influenza vaccine given 10/21/2016. Five hours post administration, developed red raised non pruritic confluent rash starting just inferior to injection site then spreading into left shoulder, left anterior chest to just below nipple. Was advised by health care provider at hospital to give child BENADRYL. The rash persisted for about 48 hours after administration of vaccine. No symptoms other than rash.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Headache, Loss of consciousness, Syncope
Clinical narrative: Patient received 3 vaccines. Approx 5 minutes later patient was standing and fainted to floor. MD responded immediately. LOC for approximately 30 seconds. Woke with head pain from hitting head on floor. Rested for about 15 minutes and able to walk w/dad.
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation error
Clinical narrative: Patient was seen for a well child visit. 3 vaccines were ordered by the provider. When PENTACEL was drawn up it was unknown box came with its own diluent. It was drawn up with sterile diluent. State was contacted along w/parent to schedule dose.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exfoliative rash, Pityriasis rosea, Rash
Clinical narrative: Rash started reportedly after HPV #2 in January 2017 with just a few lesions on upper abd., then after HPV #3 rash spread over thorax. Denies itching, fever. Rashy is scaley, oblong lesion about 2 cm over trunk and proximal legs. Pt reports rash began 1 day after HPV #3. Took BENADRYL without resolve. HPV #1 GARDASIL 11-3-16; HPV #2 GARDASIL 1-19-17; HPV #3 GARDASIL 5-22-17.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood creatine phosphokinase increased, Chorea, Culture urine negative, Dyskinesia, Full blood count normal
Clinical narrative: Pt had vaccines done 3/2/17 3/2/17. She woke up on 3/9/17 with involuntary movements of (R) hand. She was subsequently seen in ED and by neurology and diagnosed with a chorea. Mom questions if this may have been caused by vaccine. CPR slight elevated; ESR nl; nl CBC; negative flu; negative urine Cx
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Laboratory test normal, Red blood cell sedimentation rate normal
Clinical narrative: Pt had vaccines done 3/2/17 3/2/17. She woke up on 3/9/17 with involuntary movements of (R) hand. She was subsequently seen in ED and by neurology and diagnosed with a chorea. Mom questions if this may have been caused by vaccine. CPR slight elevated; ESR nl; nl CBC; negative flu; negative urine Cx
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient with redness at injection site. Varicella given in left arm.
Age: 70.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: May have more erythema and tenderness at the localized site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Skin oedema
Clinical narrative: Red, edematous skin.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient presented to pharmacy with a red circular rash where ZOSTAVAX was given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Skin warm
Clinical narrative: Redness, warmth, weeping blisters - all over 2 day time frame. Treated with KEFLEX 30 mg/kg/day divided into 3 doses over 10 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Pain, Vaccination site induration
Clinical narrative: Hardness and redness all over left upper arm where vaccine was administered. Pt. experienced some pain/soreness. Dr. diagnosed problem with infection of upper arm from vaccine.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Ongoing general fatigue, headache and swelling w/redness and rash at injection site over the past 4 days since vaccine was given.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Flank pain, Pain in extremity
Clinical narrative: Pt reported to pharmacist after 15 days, arm was sore to wrist, with severe pain, also some pain in left side.
Age: 27.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urticaria
Clinical narrative: Patient advised she had gotten hives after last dose of rabies pre-exposure vaccine. Given on 3/22/17. Per pt. she broke out in hives from head to toe. Pt reports she saw an allergy doctor who prescribed BENADRYL and steroids when she stopped meds hives returned.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a 60 year old female patient concerning herself. The patient had a medical history of lymphoma treated with an unspecified chemotherapy until an unknown date in 2016. Although her lymphoma had "cleared up" (unspecified date) her primary physician  considered her to be immunocompromised.. She was allergic to unspecified sulfonamides and alfuzosin. On 13-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, site of administration, lot number and expiration date were not reported) for prevention of shingles. Concomitant therapies included loratadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) and an unspecified nasal spray. On an unknown date in 2017, (reported as "6 to 8 weeks ago") the patient developed small bumps that looked like blisters, appearing periodically on her arms, back of legs and ankles. The patient also stated that the bumps would go away eventually, but would take a very long time to heal and usually when one bump would heal another bump would appear somewhere else on her body. The patient described the bumps as small, looking like mosquito bites, but when she scratched them, the top of skin came right off. The patient stated that she met with a physician about the event on 17-MAY-2017 she was going to see her physician on 19-MAY-2017 about the event. Lab diagnostic studies included standard blood test (unspecified), no results were provided. No treatment was given for the event. The patient did not recover from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Contraindication to vaccination, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a 60 year old female patient concerning herself. The patient had a medical history of lymphoma treated with an unspecified chemotherapy until an unknown date in 2016. Although her lymphoma had "cleared up" (unspecified date) her primary physician  considered her to be immunocompromised.. She was allergic to unspecified sulfonamides and alfuzosin. On 13-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, site of administration, lot number and expiration date were not reported) for prevention of shingles. Concomitant therapies included loratadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) and an unspecified nasal spray. On an unknown date in 2017, (reported as "6 to 8 weeks ago") the patient developed small bumps that looked like blisters, appearing periodically on her arms, back of legs and ankles. The patient also stated that the bumps would go away eventually, but would take a very long time to heal and usually when one bump would heal another bump would appear somewhere else on her body. The patient described the bumps as small, looking like mosquito bites, but when she scratched them, the top of skin came right off. The patient stated that she met with a physician about the event on 17-MAY-2017 she was going to see her physician on 19-MAY-2017 about the event. Lab diagnostic studies included standard blood test (unspecified), no results were provided. No treatment was given for the event. The patient did not recover from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: Fever for 2 days and very inflamed red swollen arm at injection site.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Anal incontinence, Autoimmune disorder, Blood test abnormal, Choking, Cough
Clinical narrative: Loss of feeling in feet, can't walk without support, drops everything, can't move fingers, hands, arms, loss bladder and bowel control, high/low blood pressure, can't move body, takes 3 hours to shower and get dressed, can't get in/out of bed, can't drive, can't stand from sitting position, can't bend over, has trouble swallowing, eating, chokes and coughs.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dysstasia, Eating disorder, Gait disturbance, Grip strength decreased
Clinical narrative: Loss of feeling in feet, can't walk without support, drops everything, can't move fingers, hands, arms, loss bladder and bowel control, high/low blood pressure, can't move body, takes 3 hours to shower and get dressed, can't get in/out of bed, can't drive, can't stand from sitting position, can't bend over, has trouble swallowing, eating, chokes and coughs.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Hypoaesthesia, Hypotension, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: Loss of feeling in feet, can't walk without support, drops everything, can't move fingers, hands, arms, loss bladder and bowel control, high/low blood pressure, can't move body, takes 3 hours to shower and get dressed, can't get in/out of bed, can't drive, can't stand from sitting position, can't bend over, has trouble swallowing, eating, chokes and coughs.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Urinary incontinence, Walking aid user
Clinical narrative: Loss of feeling in feet, can't walk without support, drops everything, can't move fingers, hands, arms, loss bladder and bowel control, high/low blood pressure, can't move body, takes 3 hours to shower and get dressed, can't get in/out of bed, can't drive, can't stand from sitting position, can't bend over, has trouble swallowing, eating, chokes and coughs.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a 60 year old male physician, referring to himself. His concurrent conditions included allergy to rifampin. The patient's medical history included a prior case of shingles before receiving ZOSTAVAX, and he stated that this was "other than indicated in the prescribing information". The patient's concomitant therapies were not provided. On 25-APR-2017 (reported as "3 weeks ago"), the patient was vaccinated with an unspecified dose of ZOSTAVAX injection, 1 dose, subcutaneously (lot# and expiration date were not provided) for shingles prevention, reconstituted with sterile diluent (manufacturer unknown). On 26-APR-2017, the day after the vaccination, he developed an itching sensation at the injection site and mentioned that he did not have any redness or swelling at the injection site. The patient did not seek medical attention and no treatment was given for the adverse event. However, the patient recovered from injection site pruritus on an unspecified date in 2017. The causal relationship between ZOSTAVAX sterile diluent (manufacturer unknown), and injection site pruritus was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and referred to an unknown number of patients of unknown ages and gender. The patients' relevant medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with improperly stored doses of VARIVAX single dose, subcutaneously (strength and dose were not reported; lot number M039316 with an expiration date 20-SEP-2018) for prophylaxis that were reconstituted with properly stored sterile diluent single dose (lot number and expiration dates were not reported). The vaccine was exposed to a temperature range from 15°F to 46°F for a total time frame of 9 hours. There was no previous temperature excursion and no data logger measure was involved. No adverse effects were reported, and product quality complaint (PQC) was not involved. This is one of two reports from the same reporter. Additional information is not expected as there was no consent to contact the physician. Sender's Comments: US-009507513-1705USA014040.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a female patient of an unknown age. Information regarding the patients' current conditions, medical history, and drug reactions or allergies was not provided. On an unspecified date in 2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot number, expiration date, anatomical location and route were not reported) for prophylaxis. The patient's concomitant therapies were not provided. It was reported that on approximately15-MAY-2017 (reported as "about one week ago"), the patient was vaccinated subcutaneously on an unspecified arm, with the second dose of GARDASIL 9 lot # M034780 and expiration date 15-MAY-2019. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a certified registered nurse prescriber, referring to a patient of an unknown age and gender.  The information regarding the patient's medical history, drug and allergy history, current condition and concomitant therapies was not provided. It was reported that on an unknown date, the patient was vaccinated intramusculary instead of subcutaneously with M-M-R II, (dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain lower, Exposure during pregnancy, Nausea, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: This spontaneous prospective pregnancy report has been received from a licensed practical nurse referring to a 12 years old female patient. The patient's current conditions included asthma and drug allergies were reported as none. On 10-APR-2017, the patient was vaccinated with the "first and only dose" of GARDASIL 9 lot # M034780 for prophylaxis (expiration date, route and anatomical location were not reported). The patient's concomitant therapies included CLARITIN. At the time of vaccination the patient reported having had a recent period (on an unknown date) and not being pregnant. It was reported that on 22-MAY-2017, the patient went to the emergency room with complaints of nausea, vomiting and lower belly pain and the chief complaint was that the patient stated that she was pregnant. An ultrasound was performed during the emergency room visit and was confirmed that the patient was 23 weeks pregnant with a last menstrual period (LMP) on 12-DEC-2016 and estimated date of delivery (EDD) on 18-SEP-2017. Additionally, unspecified intravenous fluids were administered to the patient; she also received ZOFRAN and MACROBID for urinary tract infection. The outcome of the pregnancy and of the urinary tract infection was unknown. The causality assesment between the vaccine and urinary tract infection was unknown at the time of reporting. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous prospective pregnancy report has been received from a licensed practical nurse referring to a 12 years old female patient. The patient's current conditions included asthma and drug allergies were reported as none. On 10-APR-2017, the patient was vaccinated with the "first and only dose" of GARDASIL 9 lot # M034780 for prophylaxis (expiration date, route and anatomical location were not reported). The patient's concomitant therapies included CLARITIN. At the time of vaccination the patient reported having had a recent period (on an unknown date) and not being pregnant. It was reported that on 22-MAY-2017, the patient went to the emergency room with complaints of nausea, vomiting and lower belly pain and the chief complaint was that the patient stated that she was pregnant. An ultrasound was performed during the emergency room visit and was confirmed that the patient was 23 weeks pregnant with a last menstrual period (LMP) on 12-DEC-2016 and estimated date of delivery (EDD) on 18-SEP-2017. Additionally, unspecified intravenous fluids were administered to the patient; she also received ZOFRAN and MACROBID for urinary tract infection. The outcome of the pregnancy and of the urinary tract infection was unknown. The causality assesment between the vaccine and urinary tract infection was unknown at the time of reporting. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and referred to an unknown number of patients of unknown ages and gender. The patients' relevant medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, frequency, and route of administration were not reported; lot number M038861 with an expiration date 13-MAR-2018, and lot # M043308 with expiration date of 24-APR-2018) for prophylaxis, that were reconstituted with properly stored STERILE DILUENT single dose (lot number and expiration dates were not reported). The vaccine was exposed to a temperature range from 15°F to 46°F for a total time frame of 9 hours. There was no previous temperature excursion and no data logger measure was involved. No adverse effects were reported, and product quality complaint (PQC) was not involved. This is one of two reports from the same reporter. Additional information is not expected as there was no consent to contact the physician. Sender's Comments: US-009507513-1705USA009971.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Skin: Skin is warm and dry. No rash is noted.There is erythema (right lateral arm softball size erythema.mildly warm).
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Employee reports within 15 minutes of leaving she had to pull over on side of the road with severe nausea, vomiting and dizziness. Symptoms continued for next two days with accompanied headache but is gradually subsiding.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash papular
Clinical narrative: Per mom patient broke out in erythematous raised papular bumps first to the site around each injection, over the course of hours to one week the rash began to spread to thighs, up to trunk and across arms. None on face. No significant pruritis. No new lesions after 1 week, rash beginning to fade. No vesicles.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Cough, Crying, Hypersomnia, Injection site reaction, Lymphadenopathy
Clinical narrative: Had vaccines about 1.5 weeks ago. Developed a lesion on her left thigh about 3 days after the vaccine - resolved after a couple of days. Then, in the same place, developed a pimple like lesion. That lesion has gotten larger, harder, now looking purplish. Not painful. Swollen nodes in armpits and groin. Just noticed these today. Has rash on her back as well. About 5 days ago, after getting back from grandparents' started to have random bouts of crying. Has had lower energy than normal. Sleeping more than normal. Has a occasional mild cough. + rhinorhea/congestion also starting this week. Was having fevers, but last was night before last (nearly 48 hours ago). Fevers around 102.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Skin lesion
Clinical narrative: Had vaccines about 1.5 weeks ago. Developed a lesion on her left thigh about 3 days after the vaccine - resolved after a couple of days. Then, in the same place, developed a pimple like lesion. That lesion has gotten larger, harder, now looking purplish. Not painful. Swollen nodes in armpits and groin. Just noticed these today. Has rash on her back as well. About 5 days ago, after getting back from grandparents' started to have random bouts of crying. Has had lower energy than normal. Sleeping more than normal. Has a occasional mild cough. + rhinorhea/congestion also starting this week. Was having fevers, but last was night before last (nearly 48 hours ago). Fevers around 102.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Joint range of motion decreased, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Arm warm red and swollen. Decreased ROM and fever to 102 started that night and lasted few days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored M-M-R II lot # M029230 with expiration date on 08-JUN-2018 (albumin status, dose and route of administration were not reported). The doses of vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 32 minutes. Digital data logger was used to record the excursion. The doses of vaccine did not undergo any previous temperature excursions. No adverse effects were reported. A properly stored sterile diluent (lot number and expiration date were not reported) was used to reconstitute the doses of M-M-R II. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA011196.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information was received from a physician referring a 11 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 09-APR-2017 the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly (dose, frequency, lot number and expiration date were not reported) as prevention of human papilloma virus. Concomitant medications included other unspecified vaccines at the same time of the administration of GARDASIL 9. Also in April 2017, after the vaccine was administered the patient experienced fainting. No treatment was administered. At the time of reporting, the patient was recovered from the event of fainting. The causal relationship between the event and therapy with GARDASIL 9 was not reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown dates, an unspecified number of improperly stored doses of VARIVAX (lot number L049534, expiration date 08-DEC-2017) (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (manufacturer unknown), were administered to the unspecified number of patients. No adverse effects have been reported. The doses were stored in temperatures from 47 Fahrenheit degrees to 77 Fahrenheit degrees (50 Fahrenheit degrees ) for 14 hours. There was no previous excursion reported. The digital data logger was not involved. The product quality complaint was not reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007752.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (from 47 to 77 degrees Fahrenheit for 14 hours) doses of VARIVAX (lot # L049534, expiration date 08-DEC-2017; dose and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with the properly stored sterile diluent. No adverse effect and previous excursion were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1706USA003468.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of PEDVAXHIB (dose, route of administration were not reported; lot # N003700, expiration date 01-NOV-2019), for prophylaxis. The temperature excursion ranged from 47 to 77 degrees Fahrenheit and lasted for 3 hours. It occurred once on an unspecified date and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 02-MAY-2013, the patient received the dose of HAVRIX (dose and route of administration were not provided; batch/lot# AHAV8692CA, expiration date: 18-SEP-2015). On 22-MAY-2017, the patient was vaccinated with VAQTA injection administered by intramuscular route (lot # M039055, expiration date: 22-JUL-2018; dose was not provided). The patient has not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown demographics. No information about the patient's pertinent medical history, drug reactions or allergies was provided. On an unspecified date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (also reported as "sterile water diluent"). The vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 45 days. Digital data logger was not involved in recording the temperature excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22-year-old-patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 30-AUG-2016, the patient was vaccinated with a first dose of RECOMBIVAX HB 10/1.0 microgram/ml, intramuscularly, lot # M010682, expiration date: 15-SEP-2017 (dose and anatomical location were not reported). On 13-DEC-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB 10/1.0 microgram/ml, intramuscularly, lot # M039201, expiration date: 04-NOV-2012018 (dose and anatomical location were not reported). The patient has not experienced and adverse effect. Additional information has been requested.