chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report was received from a 69-year-old female patient regarding herself. Current conditions included allergy to aspirin and an unspecified disorder of thyroid. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously in the right arm. Other suspect therapies included AFLURIA (lot#, expiration date and route not reported) administered on the same date. Concomitant medications included DILTIAZON. On an unknown date in 2008 the patient got 2 bumps on her neck. She stated she continued to get these usually on the right arm where the vaccines were given. She described them as red, warm lumps that do get a white head. After they pop, they healed up. Treatment was not rendered for the events. It was unspecified if any lab diagnostic studies were performed. Patient sought an unspecified medical attention. The outcome of the reported events were unknown. Causality was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Milia, Rash
Clinical narrative: This spontaneous report was received from a 69-year-old female patient regarding herself. Current conditions included allergy to aspirin and an unspecified disorder of thyroid. On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously in the right arm. Other suspect therapies included AFLURIA (lot#, expiration date and route not reported) administered on the same date. Concomitant medications included DILTIAZON. On an unknown date in 2008 the patient got 2 bumps on her neck. She stated she continued to get these usually on the right arm where the vaccines were given. She described them as red, warm lumps that do get a white head. After they pop, they healed up. Treatment was not rendered for the events. It was unspecified if any lab diagnostic studies were performed. Patient sought an unspecified medical attention. The outcome of the reported events were unknown. Causality was not reported. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a other health professional refers to a 57 year old patient (in source document referred as patient 1) of unknown gender with no reported medical history. On 03-APR-2013 the patient was vaccinated PNEUMOVAX23 (route and dose unknown), lot number H04196 with expiration date 19-MAR-2014 . No other suspect therapy or concomitant medication was reported. On 05-APR-2013, 3 days after onset of therapy the patient experienced cellulitis at the injection site following administration and was prescribed KEFLEX for treatment. The outcome of cellulitis at the injection site was reported as recovering/resolving. The reporters relatedness of cellulitis at the injection site to PNEUMOVAX23 is unknown. This case is linked with MARRS number 1304USA007298 (same reporter link). Additional information is not expected.
Sex: U
Vaccine: HEP, HEPA, HPV4, PPV, TD
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unknown number of patient of unknown age and gender. No medical history was reported. The healthcare worker reported that some of the improperly stored VAQTA, tetanus and diphtheria toxoids, absorbed, PNEUMOVAX23, GARDASIL and RECOMBIVAX HB might have been administered to unknown number of patients. The lot numbers and expiry dates of the vaccines were not reported. The vaccines were exposed to colder temperature excursion, temperatures ranging from 25-35 Fahrenheit (F) on multiple occasions. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patient had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 88.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 88 year old patient. on 16-APR-2013, the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot number reported as 1649AA, expiry date 21-JAN-2013, route was subcutaneous). Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient (in source document referred as patient 2) of unknown age and gender with no reported medical history. On unknown date the patient was vaccinated PNEUMOVAX23 (route and dose unknown), lot number H04196 with expiration date 19-MAR-2014. No other suspect therapy or concomitant medication was reported. On an unknown date the patient experienced cellulitis at the injection site following administration. No treatment information was reported. The outcome of cellulitis at the injection site is unknown. The reporters relatedness of cellulitis at the injection site to PNEUMOVAX23 is unknown. This case is linked with MARRS number 1304USA005056 (same reporter link). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient may have been vaccinated with improperly stored ZOSTAVAX (lot number was H022152, expiry date was 18-MAR-2014). Concomitant medications were not reported. No adverse events were reported. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Local reaction, Tenderness
Clinical narrative: Large tender local reaction approximately 6 in diameter. Lasted 4d and then began to subside (Rt arm).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Rash
Clinical narrative: Rash on back, abdomen, and back of legs started 2 days after getting GARDASIL, no rash or changes in skin at injection site. No treatment needed - this was 2nd dose of GARDASIL. Hydrocortisone prn if needed.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test abnormal, Confusional state, Cystitis, Diarrhoea
Clinical narrative: Developed flu-like symptoms after about 10 days, felt better for a day or so, then developed weakness, diarrhea, bladder infection, fever - went to ER, then blood work proved positive for MRSA - 6 weeks of severe weakness - confusion.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza like illness, Pyrexia, Staphylococcus test positive
Clinical narrative: Developed flu-like symptoms after about 10 days, felt better for a day or so, then developed weakness, diarrhea, bladder infection, fever - went to ER, then blood work proved positive for MRSA - 6 weeks of severe weakness - confusion.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Developed flu-like symptoms after about 10 days, felt better for a day or so, then developed weakness, diarrhea, bladder infection, fever - went to ER, then blood work proved positive for MRSA - 6 weeks of severe weakness - confusion.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test abnormal, Confusional state, Cystitis, Diarrhoea
Clinical narrative: See attached.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza like illness, Pyrexia, Staphylococcus test positive
Clinical narrative: See attached.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: See attached.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site swelling after injection 4/11/13 (PNEUMOVAX).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Rash
Clinical narrative: Patient presents to clinic with 5cmx5cm rash to back of neck. States that she feel sharp pain to back sometimes.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Diarrhoea, Dizziness, Flatulence, Nausea
Clinical narrative: Dizziness after 12 hours, nausea day 2, diarrhea day 3 and excessive gas day 4.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Full blood count, Injection site erythema, Pain, Rash erythematous, Tenderness
Clinical narrative: Pt states red spot came up and kept getting bigger and bigger. Pain is burning. Hurts when something brushes up against it. Does not itch, measures 40 x 45 mm (MENACTRA sight), Tdap site small red spot.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling, warmth and pain (left, anterior thigh) at DTaP site. Diagnosed as cellulitis.
Age: 31.0
Sex: F
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Chest X-ray normal, Dyspnoea, Headache, Pharyngeal oedema, Throat irritation
Clinical narrative: Immunization given at 1030 AM 3/13/13. Pt states 3/13/13 afternoon (+) itchy throat. Went to ED seen 1848 with SOB, throat swelling, headache.
Age: 1.37
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema, Oedema peripheral, Rash, Urticaria
Clinical narrative: Wheals on face, (L) arm, (R) arm, mild swelling to (L) hand, wheals on (R) hand, chest, abdomen, (R) leg, (L) leg (erythematous wheals more pronounced on (L) thigh and (R) thigh). Appeared 24 hrs. after administration of DTaP, Hib, MMR. Prescribed MILLIPRED 10/5mL 1.25 mL po BID x 5 days. Rash resolved 3 days after appearing.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 10 x 15 cm red/warm (L) deltoid, fever/chills.
Age: 18.0
Sex: M
Vaccine: HEP, HPV4, IPV, VARCEL
Symptoms: Dizziness, Vision blurred
Clinical narrative: Within 5 minutes of receiving all 4 vaccinations c/o feeling dizzy and blurry vision. Laid flat, skin warm and dry. After 5 minutes blurriness resolved. Sat up BP 116/82. Provided with Coke. Continued to c/o blurry vision better when lying flat. Rested 1 hour, continued to c/o blurry vision. Medical director recommended evaluatioin. Mother transported instructred to go to ER.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR
Symptoms: Varicella
Clinical narrative: Has had MMR/V and Varicella both on 4/7/13 this 6 year old female began with typical lesions of varicella that spread by 4/8/13 no fever or any other sxs. Symptomatic care for symptoms advised.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Initial case was received from a healthcare professional on 08 April 2013. A 57-year-old male patient received a right deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number C4278AA, on 27 February 2013. On 27 February 2013, same day, (also reported as starting two days after vaccination), the patient experienced pain at injection site. The patient continued to experience "insufferable pain" of entire right arm to date of report, ongoing. The patient required doctor visit. The patient's past medical history and illness at time of vaccination were not reported. Laboratory or diagnostic testing and treatments were not reported. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Malaise
Clinical narrative: Sat/Sun 13th/14th fatigue, got antibiotic on Monday thought it was tick bite. 4/17 - doctor confirmed shingles (face, scalp). 4/18 - eye doctor gave dose pak - near eye. 4/19 - got pain med, still not feeling well.
Age: 0.61
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: PERSISTENT HIVES.
Age: 1.48
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Proquad given with Varicella.  Proquad not order given instead of MMR. No reaction.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: High Fever 102.7; Hip Pain; Headache; Fatigue lasting through next day; No appetite.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma
Clinical narrative: No symptoms or adverse events. Mother verbally stated that child had asthma after vaccine administered. Child diagnosed in June 2012 with asthma. Flumist given 10/22/12. April 17, 2013 mother notified vaccine administrator of diagnosis, denies any symptoms or adverse events.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Induration, Swelling
Clinical narrative: Swelling and induration 2 inches below where injection was given.  No swelling or redness noted around injection site.  Area measure 2 1/2 inches by 2 1/2 inches.  Denies any pain to area.  The swelling started on 4/18/13 according to child.  Instructed to watch for increase swelling and seek further medical attention if necessary, otherwise take Benadryl and ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: 10 minutes after injection of DTaP & Varicella two whelps approximately 25 mm X 10 mm appeared on the thing with approximate 1 inch redness encircling both whelps.  B/P 86/56, Pulse 104, Respiration 20. Local reaction redness less prior to patient leaving at 4:30 p.m. Patient was adminstered Benadryl at 4:05 PM with Tylenol at 3:55 p.m.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling, paresthesia at site and surrounding area.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: BI LATERAL LOCALIZED REACTION.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Skin reaction
Clinical narrative: Localized reaction to vaccination with flu and Pneumovax-swelling and pain at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm to touch RUA.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, dizziness -30 minute recovery with fluids and ice packs.  Has history of vasovagal symptoms following immunizations.  Was able to ambulate to go home.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Child c/o itching at site to mother 3 days after Tdap given in right arm. Area was 2 to 3 inches in diameter. When seen by her Pediatrician the area was hard, erythematous and hot to touch. Diagnosis of cellulitis was made by child's physician. Child was started on antibiotic oral therapy of Amoxicillin and Bactrim on 4/15/ or 4/16. Area less swollen today according to school nurse & mom. Injection site becoming darker in color of skin.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling
Clinical narrative: Child c/o itching at site to mother 3 days after Tdap given in right arm. Area was 2 to 3 inches in diameter. When seen by her Pediatrician the area was hard, erythematous and hot to touch. Diagnosis of cellulitis was made by child's physician. Child was started on antibiotic oral therapy of Amoxicillin and Bactrim on 4/15/ or 4/16. Area less swollen today according to school nurse & mom. Injection site becoming darker in color of skin.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Barium enema, Intussusception, Respiratory syncytial virus infection, Ultrasound abdomen
Clinical narrative: PT WAS DIAGNOSED WITH RSV AND INTUSSUSCEPTION ON 2-10-2013.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Fatigue, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Pt awoke with temp of 102 degrees Fahrenheit, very tired and somewhat lethargic. Following day, pt awoke afebrile with a 2x2 red, swollen area at injection site of left deltoid.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Contusion, Erythema, Pain in extremity, Pharyngitis
Clinical narrative: Sore arm, round red spot ~7 cm in diameter with a bruise.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Sore arm, round red spot ~7 cm in diameter with a bruise.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site reaction
Clinical narrative: Local reaction at site of vaccination (left posterior arm), 5x4cm erythema, induration, mild tenderness; no fever, no chills, no rash elsewhere.
Age: 0.65
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Anxiety, Chills, Fear, Injection site erythema
Clinical narrative: Fever, chills, 1 cm area of erythema at site of PCV 13 injection (on R leg), nodule at injection site, and behavioral changes consistent with fear/anxiety/post traumatic stress from being held down.
Age: 0.65
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule, Post-traumatic stress disorder, Pyrexia
Clinical narrative: Fever, chills, 1 cm area of erythema at site of PCV 13 injection (on R leg), nodule at injection site, and behavioral changes consistent with fear/anxiety/post traumatic stress from being held down.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus
Clinical narrative: Itching/Burning Nerve Ending Sensations around sides of abdomen.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash to extremeties within 5 minutes - Benadryl given - symptoms improved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, raised area (bump) approximately golfball sized.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Full blood count normal, Metabolic function test normal, Tremor
Clinical narrative: Tremor lasting 15 minutes. When seen in ER, temp was 103.7.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Nausea, vomiting, dizziness, injection site pain, redness and swelling. Treating arm with KEFLEX and BENADRYL.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, dizziness, injection site pain, redness and swelling. Treating arm with KEFLEX and BENADRYL.
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 12 year old patient of unknown age and gender. No medical history was reported. On 17-APR-2013 (reported as today), the patient was vaccinated with an expired dose of MMR II (lot # 667968/0346AA, expiry date: 07-MAR-2013), 0.5 ml, subcutaneously. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised, Rash maculo-papular, Skin exfoliation
Clinical narrative: Patient is 4 years old who received on 4/1/2013: PROQUAD and KINRIX and he came back a 4/19/2013 with maculopapular rash all over body, face, neck, extremities and torso with whole skin peeling of his palms. No fever. No cough. No other complaint.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Patient reports immediate swelling, hard red golf ball size knot at injection site. Painful lasted app 1 1/2 weeks, she also had dizzy - lightheaded feeling after shot, vomiting reported on 4-12-13.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Vomiting
Clinical narrative: Patient reports immediate swelling, hard red golf ball size knot at injection site. Painful lasted app 1 1/2 weeks, she also had dizzy - lightheaded feeling after shot, vomiting reported on 4-12-13.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Capillary fragility, Injection site erythema, Injection site reaction, Injection site swelling, Laboratory test normal
Clinical narrative: Rash, started 4-6-13, then leg red, swollen with broken vessels, 4-9-13 at hospital for evaluation of blood clot. Neg work up at hospital refer to Hematology. 4-11-13 - all symptoms have completely resolved.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash
Clinical narrative: Rash, started 4-6-13, then leg red, swollen with broken vessels, 4-9-13 at hospital for evaluation of blood clot. Neg work up at hospital refer to Hematology. 4-11-13 - all symptoms have completely resolved.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at site. Pain at site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Mild discomfort at site ((L) deltoid) 1st 36 hours, then increasing pain shoulder to elbow and red, raised, non-itchy area over deltoid - one inch streak circumscribing arm. Unable to touch or sleep on (L) side for 1 week, even with use of warm pack (to underarm) and Hydrocod. Pink area +1-2 inch diameter mod. firm and sl. tender to pressure to this date.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Mild discomfort at site ((L) deltoid) 1st 36 hours, then increasing pain shoulder to elbow and red, raised, non-itchy area over deltoid - one inch streak circumscribing arm. Unable to touch or sleep on (L) side for 1 week, even with use of warm pack (to underarm) and Hydrocod. Pink area +1-2 inch diameter mod. firm and sl. tender to pressure to this date.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (L) arm, redness, heat, et edema around inj site of Varicella.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Edema, heat et redness around injection site of Varicella.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm, Vaccination complication
Clinical narrative: ZOSTAVAX vaccine administered 4/8. Patient came in 4/19 to tell us she had a rxn to the vaccine (large area swollen, red, hot and itching.
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Injury associated with device, Oedema peripheral, Skin tightness
Clinical narrative: This spontaneous report was received from a 26 years old, female licensed practical nurse reporting on herself with no pertinent medica; history or drug reactions or allergies. The nurse noted that on 12-APR-2013 while preparing a dose of (Merck) PROQUAD (lot number and expiration date not reported) for a patient, she inadvertently "stuck" herself on her finger with a needle that contained the (merck) PROQUAD. Starting on 13-APR-2013 she noted "her finger was swollen and that the skin on her finger was tight". The nurse's present status was not recovered. The nurse stated that no treatment was given for the events. The nurse reported that none lab diagnostic studies were performed. The reported did not seek medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed red, swollen, warm to touch cellulitis to (R) upper thigh 24 hours after vaccines given. Redness spread to 3.5 inch x 3.5 inch area by 3/17/13. AUGMENTIN prescribed. Pt had T-max of 100.4 on 3/17/13. On follow-up, infection resolved and pt afebrile 48 hours after starting Abx.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Injection site reaction, erythema 11.5cm x 10cm at site, reaction was at KINRIX site. Treatment: warm compresses.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Nervousness
Clinical narrative: Mom reports child c/o respiratory difficulty and nervous 15 minutes after receiving vaccines and went to ER for treatment. Reports child on prednisone now.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding an unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with one dose of GARDASIL (dose, route, indication, lot # and expiration date not reported). The reporter stated that the patients were administered with improperly stored GARDASIL for the past 3 years at the office. She stated that she wasn't aware of the recommend label storage temperature of GARDASIL being 36 F to 46 F, and noted that over the past 3 years their GARDASIL doses have had an unspecified number of low temperature excursions (as low as 30F-31F) and unspecified number of high temperature excursions (as high as 48F-54F) for unspecified time period on unspecified dates. No adverse effects were reported. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to two patients of unknown age and gender. On 13-FEB-2013, the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Follow up information has been received from the nurse concerning an 8weeks female patient with no pertinent medical history, no drug reactions or allergies and with no illness at time of vaccination who on 13-FEB-2013 at 11:27 was vaccinated with the first expired dose of ROTATEQ, the second dose of RECOMBIVAX HB (Lot # 0384AE) IM, a first dose of PENTACEL (Lot # C4358AA) IM and a first dose of PREVNAR 13 (Lot # G15075) IM. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 51 year old patient. On 27-MAR-2013 the patient was vaccinated with VARIVAX (Merck) (lot # not reported) 0.5 ml, once, subcutaneous. No other co suspect were reported. No concomitant therapy was reported. The physician reported that on 13-APR-2013, the patient developed an unspecified rash. The physician requested to complete a PCR analysis for rash that patient developed. The patient sought medical attention at office visit. The outcome of the patient received VARIVAX (Merck) and developed an unspecified rash was unknown. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Abasia, Pain in extremity, Phlebitis, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to one female patient seen in hospital obgyn (obstetrician/gynecologist) clinic who was of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patient developed swelling and phlebitis. The physician reported that the patient had a reaction severe enough to seek attention in emergency room. The outcome of phlebitis and swelling was unknown. Additional information was received from a pharmacist who called back and reported that the patient was administered PNEUMOVAX 23 (in the thigh after being given an epidural and after delivery of the baby. He noted that patient have complained of severe pain in his/her legs and had not been able to walk after being given PNEUMOVAX 23 (and also have needed to come back to the emergency room for unspecified treatment). He provided PNEUMOVAX 23 lot # H020684 with expiration date 17-APR-2013 and lot # H018441 with unspecified expiration date. "Lot check requested" by the pharmacist. At the time of report, the outcome of patient was unknown. This is one of the several reports from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a 5 year old female patient. On an unknown date, the patient was vaccinated with the first dose of (merck) PROQUAD (lot number, expiry date and dose unspecified), subcutaneously. On an unknown date, the patient experienced redness, itching and swelling around the injection site. It was a 9 inch area that was affected on the arm of the patient. The patient sought medical attention (phone call to office). The patient was treated with TYLENOL. It was unspecified if any lab tests were performed. On an unknown date (reported as the next day), the patient recovered from all the events. The relatedness for redness, itching and swelling around the injection site was unknown for (merck) PROQUAD. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a 5 year old female patient. On an unknown date, the patient was vaccinated with the first dose of (merck) PROQUAD (lot number, expiry date and dose unspecified), subcutaneously. On an unknown date, the patient experienced redness, itching and swelling around the injection site. It was a 9 inch area that was affected on the arm of the patient. The patient sought medical attention (phone call to office). The patient was treated with TYLENOL. It was unspecified if any lab tests were performed. On an unknown date (reported as the next day), the patient recovered from all the events. The relatedness for redness, itching and swelling around the injection site was unknown for (merck) PROQUAD. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a 5 year old female patient. On an unknown date, the patient was vaccinated with the first dose of (merck) PROQUAD (lot number, expiry date and dose unspecified), subcutaneously. On an unknown date, the patient experienced redness, itching and swelling around the injection site. It was a 9 inch area that was affected on the arm of the patient. The patient sought medical attention (phone call to office). The patient was treated with TYLENOL. It was unspecified if any lab tests were performed. On an unknown date (reported as the next day), the patient recovered from all the events. The relatedness for redness, itching and swelling around the injection site was unknown for (merck) PROQUAD. Additional information has been requested.
Age: 1.84
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PPV
Symptoms: Injection site mass, Irritability, Pyrexia, Rash
Clinical narrative: Mild fever, irritability, rash on head and neck, lump at shot location.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Palpitations, Paraesthesia
Clinical narrative: Numbness and tingling in my entire arm and hand, on the arm that I received the 1st Gardasil vaccine on, lasting at least 4 hours. Numbness is gone since I've woken up. I also noticed heart palpitations, which I usually only get from caffeine. I hadn't had any caffeine.  Pain at injection site still persists. Still watching out for other issues.
Age: 38.0
Sex: F
Vaccine: IPV, TDAP, TYP, YF
Symptoms: Abdominal pain upper, Chills, Dizziness, Feeling of body temperature change, Headache
Clinical narrative: Shivering, altering between hot and cold, pains shooting through legs and arms, headache, stomache, feeling faint when standing or walking for any length of time. I've had vaccines before and never had this type of reaction.
Age: 38.0
Sex: F
Vaccine: IPV, TDAP, TYP, YF
Symptoms: Pain in extremity
Clinical narrative: Shivering, altering between hot and cold, pains shooting through legs and arms, headache, stomache, feeling faint when standing or walking for any length of time. I've had vaccines before and never had this type of reaction.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Hypotension, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: High fever, hypotension, tachycardia, lethargy, major swelling and redness at injection site.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Tachycardia
Clinical narrative: High fever, hypotension, tachycardia, lethargy, major swelling and redness at injection site.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Feeling abnormal, Headache, Immune system disorder, Injection site erythema
Clinical narrative: Redness and itching at injection site. Pt reported not feeling good. Pt reported a pressure feeling both sides of chest right beneath collar bone and strange feeling in face. Headache whole of next day. Does not normally get headache - Technician took Pt to emergency care. Was examined, PA. said Pt immune system went hay wire! Pt was brought back to PH. Pt drove home, called and said she was O.K.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise
Clinical narrative: Redness and itching at injection site. Pt reported not feeling good. Pt reported a pressure feeling both sides of chest right beneath collar bone and strange feeling in face. Headache whole of next day. Does not normally get headache - Technician took Pt to emergency care. Was examined, PA. said Pt immune system went hay wire! Pt was brought back to PH. Pt drove home, called and said she was O.K.
Age: 28.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 28 year old patient. On an unknown date the patient was inadvertently vaccinated with ZOSTAVAX instead of (Merck) VARIVAX. No adverse effect reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Dizziness, Fatigue, Feeling cold, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself. The patient never had a prior vaccine reaction. 30 years ago, in approximately April 1983, the patient had prior chest pain from an unspecified source. On 26-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The patient had no concomitant medication. The patient explained that after having her ZOSTAVAX she walked into the waiting room and immediately felt tingling all the way to her toes, a shaky and cold feeling came over her, she developed mild itching without a rash, and mild chest pain. The patient talked to doctor. No treatment was given for the events. The patient stated that she had to sit down for 2 hours in an attempt to alleviate the symptoms and the chest pain and NOVOCAIN like feeling from her nose to her chin had persisted since the event took place. The patient went on to mention that although she felt that she was recovering at this time, she also noticed that her 17 year old son, who did not receive the vaccine began to demonstrate some of the same symptoms including the chest pain. The outcome of the events was reported as recovering. The patient also stated that ALEVE caused facial swelling. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Nausea, Pain in extremity, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself. The patient never had a prior vaccine reaction. 30 years ago, in approximately April 1983, the patient had prior chest pain from an unspecified source. On 26-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The patient had no concomitant medication. The patient explained that after having her ZOSTAVAX she walked into the waiting room and immediately felt tingling all the way to her toes, a shaky and cold feeling came over her, she developed mild itching without a rash, and mild chest pain. The patient talked to doctor. No treatment was given for the events. The patient stated that she had to sit down for 2 hours in an attempt to alleviate the symptoms and the chest pain and NOVOCAIN like feeling from her nose to her chin had persisted since the event took place. The patient went on to mention that although she felt that she was recovering at this time, she also noticed that her 17 year old son, who did not receive the vaccine began to demonstrate some of the same symptoms including the chest pain. The outcome of the events was reported as recovering. The patient also stated that ALEVE caused facial swelling. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Tremor
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself. The patient never had a prior vaccine reaction. 30 years ago, in approximately April 1983, the patient had prior chest pain from an unspecified source. On 26-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The patient had no concomitant medication. The patient explained that after having her ZOSTAVAX she walked into the waiting room and immediately felt tingling all the way to her toes, a shaky and cold feeling came over her, she developed mild itching without a rash, and mild chest pain. The patient talked to doctor. No treatment was given for the events. The patient stated that she had to sit down for 2 hours in an attempt to alleviate the symptoms and the chest pain and NOVOCAIN like feeling from her nose to her chin had persisted since the event took place. The patient went on to mention that although she felt that she was recovering at this time, she also noticed that her 17 year old son, who did not receive the vaccine began to demonstrate some of the same symptoms including the chest pain. The outcome of the events was reported as recovering. The patient also stated that ALEVE caused facial swelling. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Feeling abnormal, Feeling cold, Nervousness, Paraesthesia
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself. The patient never had a prior vaccine reaction. 30 years ago, in approximately April 1983, the patient had prior chest pain from an unspecified source. On 26-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The patient had no concomitant medication. The patient explained that after having her ZOSTAVAX she walked into the waiting room and immediately felt tingling all the way to her toes, a shaky and cold feeling came over her, she developed mild itching without a rash, and mild chest pain. The patient talked to doctor. No treatment was given for the events. The patient stated that she had to sit down for 2 hours in an attempt to alleviate the symptoms and the chest pain and NOVOCAIN like feeling from her nose to her chin had persisted since the event took place. The patient went on to mention that although she felt that she was recovering at this time, she also noticed that her 17 year old son, who did not receive the vaccine began to demonstrate some of the same symptoms including the chest pain. The outcome of the events was reported as recovering. The patient also stated that ALEVE caused facial swelling. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swelling face
Clinical narrative: This spontaneous report as received from a 61 year old female patient refers to herself. The patient never had a prior vaccine reaction. 30 years ago, in approximately April 1983, the patient had prior chest pain from an unspecified source. On 26-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. The patient had no concomitant medication. The patient explained that after having her ZOSTAVAX she walked into the waiting room and immediately felt tingling all the way to her toes, a shaky and cold feeling came over her, she developed mild itching without a rash, and mild chest pain. The patient talked to doctor. No treatment was given for the events. The patient stated that she had to sit down for 2 hours in an attempt to alleviate the symptoms and the chest pain and NOVOCAIN like feeling from her nose to her chin had persisted since the event took place. The patient went on to mention that although she felt that she was recovering at this time, she also noticed that her 17 year old son, who did not receive the vaccine began to demonstrate some of the same symptoms including the chest pain. The outcome of the events was reported as recovering. The patient also stated that ALEVE caused facial swelling. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Diarrhoea, Erythema, Feeling hot, Induration, Purulent discharge
Clinical narrative: Indurated, redness, warmth, with liquid and pus.  No fever/nausea/vomiting.  Some diarrhea reported. Drainage require for treatment to elevate pus.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Eczema, Haemorrhage, Headache, Pyrexia, Rash erythematous
Clinical narrative: Headache and fever for 7 days. Eczema flare up on day 4 of fever on elbows and knees (large red oozing swollen bumps). On day 6 of fever, rash (small raised bumps) spread all over her legs and a few on her trunk. Appear to look like measles. We have pictures of the rashes. Four pound weight loss in one week. Weight on 8/4/12: 96 pounds. Weight on 8/20/12: 92 pounds.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform, Weight decreased
Clinical narrative: Headache and fever for 7 days. Eczema flare up on day 4 of fever on elbows and knees (large red oozing swollen bumps). On day 6 of fever, rash (small raised bumps) spread all over her legs and a few on her trunk. Appear to look like measles. We have pictures of the rashes. Four pound weight loss in one week. Weight on 8/4/12: 96 pounds. Weight on 8/20/12: 92 pounds.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Area of medium erythema centered on vaccine site on left deltoid induration in the center, less than 2 cm in diameter.  Small amount of warmth, no swelling, not painful.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site swelling, Pain in extremity
Clinical narrative: Left arm swollen from shoulder to 2-3 inches from elbow, red down arm and extremely painful.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination site erythema, Vaccination site warmth, Wrong drug administered
Clinical narrative: 3.5 cm circular diameter erythema, warmth, no induration. Vacc site (L) deltoid. Pt given 400mg po Ibuprofen and 10mL of 12.5mg/5mL BENADRYL on 4/21/13 at 1535. Wrong vaccine administered 4/19/13 by MA. DTaP given should have been Tdap.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 17-APR-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date reported as 671416/1241AA and 12-APR-2013 respectively, dose and route unspecified) as the first dose. No concomitant medications were reported. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX 23 (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. Approximately on an unknown date in 1998 (reported as 10-15 years ago), the patient experienced severe allergic reaction. The patient did not specify if it was life threatening or if any emergency measures were used. The patient sought an unspecified medical attention. An unspecified treatment was given to the patient. It was unspecified if any lab tests were performed. The outcome of severe allergic reaction was unknown. The relatedness for severe allergic reaction was unknown for PNEUMOVAX 23. This is one of the two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX 23 (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. On an unknown date, the patient experienced hives. The patient did not specify if it was life threatening or if any emergency measures were used. The patient sought an unspecified medical attention. An unspecified treatment was given to the patient. It was unspecified if any lab tests were performed. The outcome of hives was unknown. The relatedness for hives was unknown for PNEUMOVAX 23. This is one of the two reports from the same source. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See copy.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Immediate post-injection reaction, Infection, Pain, Pruritus
Clinical narrative: Case number PHHY2013US000787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469855) website on 02 Jan 2013 with a follow-up received from the Quality Assurance Department (reference number: 203375) on 09 Jan 2013 with a follow-up received from the Quality Assurance Department (reference number: 208982) on 15 Apr 2013. This case refers to a 62-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1206701) intramuscularly and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly on 30 Sep 2012. On the same day, she experienced itching, blotches, redness and severe pain immediately after vaccination. She also experienced fever with 102 degrees Celsius, which later diagnosed that the arm was infected, said by physician after emergency visit. The outcome of the events was reported as not recovered. The seriousness and causality of the events were not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1206701) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the Quality Assurance Department (reference number: 203375) on 09 Jan 2013: Update reference number. Follow-up received from the Quality Assurance Department on 15 Apr 2013: Updated batch review report.