chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Initial report received from a Health care professional on 13 April 2012. A 51-year-old female patient, whose medical history and concomitant medications were not reported, had received a 2nd dose of IMOVAX on 09 April 2012. (Batch number: G1109-2, route and site of administration were not reported). It was reported that the patient received 1st dose on IMOVAX on 05 April 2012(lot number, route and site of administration were not reported). The caller stated that on 13 April 2012, the patient took IMOVAX vaccine from Pharmacy to get it administered from her own HCP as third dose for Post exposure Rabies. On an unknown date the patient complained of feeling awful, general malaise and reported that she feels like she's going to die. It was reported that the patient had not received third dose of IMOVAX vaccine. On an unspecified date outcome of the event was reported as not-recovered. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Initial report received from a healthcare professional on 01 November 2012. A 34-year-old female patient received IMOVAX rabies vaccine (lot number, route and site of vaccination was not reported) and also received RIG manufacturer unknown (lot number, route and site of vaccination was not reported) on 05 September 2012. The patient's illness at the time of vaccination includes bat bite. The patient had Food allergies and was allergic to Flu vaccine, FLONASE, DEMEROL, Codeine and CIPRO; and had medical history of Fibromyalgia, Blindness, GERD, Cataracts, "orthostatis", Pituitary Adenoma, Ehlers-Danlos Syndrome Type III. The patient also had received an intramuscular dose of IMOVAX rabies vaccine (lot number H1180-1) in right deltoid on 08 September 2012 and on 12 September 2012; and received an intramuscular dose of IMOVAX rabies (Lot number: H1091-1) on the left deltoid on 19 September 2012 and 03 October 2012. After completion of a post exposure series for Bat bite, on an unknown date the rabies IgG serum titer was checked and was found to be low "0.4 international unit/ml". Laboratory investigations and corrective treatments were not reported. The patient's outcome was reported as recovered. Documents held by sender: none. Follow-up information received from healthcare professional on 23 January 2013. The reporter's facility administered last four doses of the vaccine. According to the reporter, the patient was very anxious and did not feel that she was treated well at the initial facility. The patient also may have had an allergic reaction to the RIG because she had no issues after each of the four vaccines administered at the reporter's facility. The initial titer was drawn two weeks after the last IMOVAX dose and has since been drawn again and the patient ended up achieving a good titer (exact level was not reported). No treatments were provided.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial information received from a Health Care Professional on 11 July 2012 and follow-up information received on 12 July 2012. A 21 year old female patient; whose no relevant medical history and concomitant medications were not reported; had received second dose of IMOVAX intramuscular in the left deltoid area (Lot number: G1377-1) on an10 July 2012. Within one hour of vaccination, patient felt she had flu like symptoms. The injection site became red, hard and the area affected was 3.5 inch circle. The area was also warm to touch. The patient did apply ice pack to the arm. No other corrective medication or laboratory investigations were reported. The outcome was not recovered at the time of report. Documents held by the sender: Picture of affected area. Follow-up information received from Healthcare professional on 04 December 2012: It was reported that, the patient had 5 days of redness and soreness and treated with ice and Ibuprofen. The patient was fully recovered on an unspecified date of "October 2012".
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Pain
Clinical narrative: Initial information received from a Health Care Professional on 11 July 2012 and follow-up information received on 12 July 2012. A 21 year old female patient; whose no relevant medical history and concomitant medications were not reported; had received second dose of IMOVAX intramuscular in the left deltoid area (Lot number: G1377-1) on an10 July 2012. Within one hour of vaccination, patient felt she had flu like symptoms. The injection site became red, hard and the area affected was 3.5 inch circle. The area was also warm to touch. The patient did apply ice pack to the arm. No other corrective medication or laboratory investigations were reported. The outcome was not recovered at the time of report. Documents held by the sender: Picture of affected area. Follow-up information received from Healthcare professional on 04 December 2012: It was reported that, the patient had 5 days of redness and soreness and treated with ice and Ibuprofen. The patient was fully recovered on an unspecified date of "October 2012".
Sex: F
Vaccine: RAB, TTOX
Symptoms: Oedema peripheral, Pain, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 20 February 2013 and Follow-up information received on 25 February 2013. A female patient (age unknown) had received 5.0 ml of first dose of HRIG (Imogam), (lot number H1290-2) at infiltrated at site of scratch and 5.0 ml administered intramuscularly at separate site in gluteal area on 13 February 2013. The patient also received IMOVAX RABIES (lot number G1377-1, route and anatomical site of administration were not reported) and Tetanus shot (Manufacturer, batch number, route and site of administration were unknown), on unspecified date. The patient's illness at the time of vaccination and pre-existing physicain-diagnosed allergies, birth defects and medical conditions were unknown. On 14 February 2013, next day, the patient complained of distal swelling in the hand, tingling and pain and some swelling in forearm which had persisted, perhaps slightly decreasing over the past 7 days. The scratch area on hand/forearm was not red or warm and the reporter stated that the treating physicain ruled out infection. The patient had visited a hand surgeon because of her reported symptoms on an unspecified date and there was no evidence of a compartment syndrome in the report. The physician treated the swelling with a compression glove. Laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tuberculin test negative
Clinical narrative: Father noticed redness on upper (L) arm 5-1-13 when child got up. On 5-3-13 upper (L) arm red, warm to touch, and swollen on outer arm. Redness & swelling around arm almost like band but does not go to back of arm approx 4-5" wide. Father states sx increased over days. Sent to PCP for eval.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician regarding a 76 year old male patient. The patient's medical history, drug reactions or allergies were not provided. On 19-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not provided). On 07-APR-2013, the patient developed shingles on his right flan after received a dose of ZOSTAVAX. The patient received an unspecified treatment method for the patient's adverse event. The patient sought medical attention, a physician saw him. On an unspecified date, the patient recovered from the adverse event. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Local reaction, Pain
Clinical narrative: Large, painful, local rxn. 8 cm diameter raised about 4 cm, Well demarcated. Out break of HSV #1 - lips and mouth.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of redness/warm to touch at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain, redness from shoulder to elbow (L) deltoid - Dtap.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 6 inch wide, raised, hot area with some pain, around the injection area x 7 days. (pharmacist stuck her twice).
Age: 2.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Blood culture negative, Condition aggravated, Convulsion, Full blood count normal, Neurological examination
Clinical narrative: Patient woke up form nap early afternoon on 5/5/13 noted to be hot and then had a 1.5 min seizure. He vomited once after seizure. This patient has a history of seizure-none in last year until now. Patient was transported to hospital for evaluation.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Skin warm, Vomiting
Clinical narrative: Patient woke up form nap early afternoon on 5/5/13 noted to be hot and then had a 1.5 min seizure. He vomited once after seizure. This patient has a history of seizure-none in last year until now. Patient was transported to hospital for evaluation.
Age: 30.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: At 48 hrs - 8 cm are of redness warmth and induration at injection site. Cold pack, BENADRYL.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Fatigue, Headache, Mycobacterium tuberculosis complex test negative, Sensation of foreign body
Clinical narrative: Approx 3 hours after MMR pt felt "fatigued", slept for 2 hours. On awakening, felt "lump in throat," difficulty swallowing, head pressure. Took acetaminophen and pushed fluids rest of day. Afebrile. Cont to rest on 5/2/13, still difficulty swallowing. After full nights rest, on 5/3/13 the pt feels "fine". Declined any medical treatment. Denies sx.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Pain and heat of left anterior thigh with raised lesion that was erythematous with circumscribed edges (entire anterior thigh).
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Dysstasia, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Pvax injected (L) buttock/thigh. Few hours later, pain extending from injection site to knee, muscle felt affected. Next day, pain, ache generalized, temp 100.4 F. Hard to stand on leg (not warm); nausea.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Pvax injected (L) buttock/thigh. Few hours later, pain extending from injection site to knee, muscle felt affected. Next day, pain, ache generalized, temp 100.4 F. Hard to stand on leg (not warm); nausea.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 5-9-13 Spreading redness, swelling and warmth whcih appeared two days after receiving T-Dap and Menactra.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 5-9-13 Spreading redness, swelling and warmth which appeared two days after receiving Tdap and MENACTRA.
Age: 0.22
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 month and several weeks old patient. Pertinent medical history and drug reactions/allergies were not reported. On 30-APR-2013, the patient was given an expired dose of oral ROTATEQ (Lot # 0923AA, expiration date 25-APR-2013) (dose, frequency and therapy route were not reported). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Dizziness, Fatigue, Headache, Immunisation, Immunodeficiency
Clinical narrative: On 04/25/13 in Dr office after immunology blood work determined an immunodeficiency he required re-booster of two vaccines. Per child mother advised 6 hours after administration of vaccines he was tired headache, dizziness, "worn out" and right arm pain was 100% better 24hr after vaccines given.
Age: 10.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Immunology test abnormal, Pain in extremity
Clinical narrative: On 04/25/13 in Dr office after immunology blood work determined an immunodeficiency he required re-booster of two vaccines. Per child mother advised 6 hours after administration of vaccines he was tired headache, dizziness, "worn out" and right arm pain was 100% better 24hr after vaccines given.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered pharmacist regarding an 81 year old female patient. The patient's medical history, drug reactions or allergies were not provided. The pharmacist stated that a physician told her that on 07-MAY-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route was not provided) (lot # 669187/1543Z, expiration date 06-FEB-2012). No adverse effect reported at this time. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TD, VARCEL
Symptoms: Blister, Swelling face
Clinical narrative: Child awoke with swollen face and vesicles on hands. Mother treated with Benadryl.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Fever, rash, itching. Meds: BENADRYL 12.5 mg/5mL Mupiracin  tropical ointment 2% Ibuprofen oral drops suspension 50mg/1.25mL.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Hypoaesthesia, Influenza like illness, Injection site erythema
Clinical narrative: Headache night of injection, redness, swelling & pain at site of injection, high fever & flu like symptoms 24 hrs post injection; by second day swelling pain & redness extends from armpit to elbow..tingling & numbness extends to hand.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Paraesthesia, Pyrexia, Swelling
Clinical narrative: Headache night of injection, redness, swelling & pain at site of injection, high fever & flu like symptoms 24 hrs post injection; by second day swelling pain & redness extends from armpit to elbow..tingling & numbness extends to hand.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain, Skin warm, Urticaria
Clinical narrative: Client states that it started off just a little red, but now is an area about the size of the palm of her hand, it is hot to the touch and has a hard welted area in center. Client states it is very painful to touch. Advised client to apply cold compress to the area and if symptoms worsen to follow up with physician for evaluation.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, and swelling at site.
Age: 60.0
Sex: M
Vaccine: TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None - Patient received vaccine in Feb 06 2013 and then again on 5-9-2013. No adverse effect noted. NO allergic reaction. Patient felt fine.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Increased upper airway secretion, Sinusitis
Clinical narrative: Persistent sinusitis infection, coughing, and excess mucous secretion that continues almost 9 months after the shot, although improving slowly. Previously had not had the flu or a cold in 25-30 years.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: States that woke up next am and arm was so sore that she could not hardly move it. This went on for several days. Had to schedule appt with doctor on 5/9/13 to be evaluated. Trial Flexeril 5 mg QHS prn.  Motrin 800 mg Q 8 hrs prn.  Tylenol 1 g Q 8 hrs prn OTC.
Age: 1.6
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Swelling
Clinical narrative: Rash on entire body starting on left arm.  Then moving up the neck to face and legs with minimal swelling. Physician recommended otc Benadryl for 48hrs every 6hrs.
Age: 29.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Chills, Hypogeusia, Pyrexia
Clinical narrative: Hypogeusia, appx 24 hours. Chills, fever, usual stuff for Tdap.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dysstasia, Mobility decreased, Myalgia
Clinical narrative: Severe joint and muscle pain that never went away. My doctor only gave me an anti-inflammatory to dull the pain. I am unable to move sometimes or stand for long periods of time at my job. It has been 7 months since the flu shot and it has not gotten any better.
Age: 33.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood culture negative, C-reactive protein increased, Cellulitis
Clinical narrative: At 11:30AM patient had Tdap in left deltoid, and both meningococcal and pneumococcal vaccines in the right deltoid. By 7:00 PM, patient developed severe pain, dizziness, fatigue, chills, myalgias, arthralgias, headache, and increasing redness in the right deltoid area at the site of pneumococcal and meningococcal vaccine administration. She was seen by PCP then sent to the ED one day later, was admitted. White blood cell count elevated at 27,000. Fever noted. She was admitted to hospital. Started on broad spectrum antibiotics. Redness in right deltoid was severe and associated with severe tenderness. Patient not septic. Felt to be a reactive phenomenon rather than infectious. General symptoms of malaise, chills etc. regressed. On 5/9/13 discharged to home in stable condition with plan to see PCP the next day (today).
Age: 33.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Chest X-ray normal, Chills, Dizziness, Fatigue, Headache
Clinical narrative: At 11:30AM patient had Tdap in left deltoid, and both meningococcal and pneumococcal vaccines in the right deltoid. By 7:00 PM, patient developed severe pain, dizziness, fatigue, chills, myalgias, arthralgias, headache, and increasing redness in the right deltoid area at the site of pneumococcal and meningococcal vaccine administration. She was seen by PCP then sent to the ED one day later, was admitted. White blood cell count elevated at 27,000. Fever noted. She was admitted to hospital. Started on broad spectrum antibiotics. Redness in right deltoid was severe and associated with severe tenderness. Patient not septic. Felt to be a reactive phenomenon rather than infectious. General symptoms of malaise, chills etc. regressed. On 5/9/13 discharged to home in stable condition with plan to see PCP the next day (today).
Age: 33.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Malaise, Myalgia
Clinical narrative: At 11:30AM patient had Tdap in left deltoid, and both meningococcal and pneumococcal vaccines in the right deltoid. By 7:00 PM, patient developed severe pain, dizziness, fatigue, chills, myalgias, arthralgias, headache, and increasing redness in the right deltoid area at the site of pneumococcal and meningococcal vaccine administration. She was seen by PCP then sent to the ED one day later, was admitted. White blood cell count elevated at 27,000. Fever noted. She was admitted to hospital. Started on broad spectrum antibiotics. Redness in right deltoid was severe and associated with severe tenderness. Patient not septic. Felt to be a reactive phenomenon rather than infectious. General symptoms of malaise, chills etc. regressed. On 5/9/13 discharged to home in stable condition with plan to see PCP the next day (today).
Age: 33.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Pain, Protein urine absent, Pyrexia, Ultrasound scan abnormal, Urinary casts absent
Clinical narrative: At 11:30AM patient had Tdap in left deltoid, and both meningococcal and pneumococcal vaccines in the right deltoid. By 7:00 PM, patient developed severe pain, dizziness, fatigue, chills, myalgias, arthralgias, headache, and increasing redness in the right deltoid area at the site of pneumococcal and meningococcal vaccine administration. She was seen by PCP then sent to the ED one day later, was admitted. White blood cell count elevated at 27,000. Fever noted. She was admitted to hospital. Started on broad spectrum antibiotics. Redness in right deltoid was severe and associated with severe tenderness. Patient not septic. Felt to be a reactive phenomenon rather than infectious. General symptoms of malaise, chills etc. regressed. On 5/9/13 discharged to home in stable condition with plan to see PCP the next day (today).
Age: 33.0
Sex: F
Vaccine: MNQ, PPV, TDAP
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: At 11:30AM patient had Tdap in left deltoid, and both meningococcal and pneumococcal vaccines in the right deltoid. By 7:00 PM, patient developed severe pain, dizziness, fatigue, chills, myalgias, arthralgias, headache, and increasing redness in the right deltoid area at the site of pneumococcal and meningococcal vaccine administration. She was seen by PCP then sent to the ED one day later, was admitted. White blood cell count elevated at 27,000. Fever noted. She was admitted to hospital. Started on broad spectrum antibiotics. Redness in right deltoid was severe and associated with severe tenderness. Patient not septic. Felt to be a reactive phenomenon rather than infectious. General symptoms of malaise, chills etc. regressed. On 5/9/13 discharged to home in stable condition with plan to see PCP the next day (today).
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Skin tightness
Clinical narrative: Left upper arm with about 4cm light erythematous area which is tight and mildly tender to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Oedema peripheral, Skin reaction, Skin warm
Clinical narrative: Patient's arm is red, swollen, and warm to touch. Patient's upper arm was measured: 4.5 inches in length, 5 inches width. Patient advised to visit a medical doctor. When patient received vaccines the parent was advised to place cool wash cloths for the redness and swelling and give Tylenol if patient developed a fever.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting.  Fever lasted one day.  Vomiting lasted 3 days, non-bilious.  (This also occurred with her 2mo immunizations but it was not reported since at that time I didn't think it was a cause of the vaccine.)
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red itchy bump on Right Thigh around injection site. No pain or fever.
Age: 1.52
Sex: F
Vaccine: HEPA, MMR
Symptoms: Injection site inflammation, Injection site reaction, Injection site warmth, Skin lesion, Urticaria
Clinical narrative: Hive like rash to the entire body; 3cm inflamed hot lesion at the site of injection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Anxiety, Cardiac monitoring normal, Chest pain, Dyspnoea
Clinical narrative: Vaccine given 8:30 AM. Severe abdominal pain/N/V began 10:30. Chest pain and SOB --> Anxiety followed. Lorazepam given in Emerg. Room - EKG - normal.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram normal, Laboratory test, Nausea, Vomiting
Clinical narrative: Vaccine given 8:30 AM. Severe abdominal pain/N/V began 10:30. Chest pain and SOB --> Anxiety followed. Lorazepam given in Emerg. Room - EKG - normal.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Dtap/IPV given (R) thigh; 5/3/13 pt presented with 5" x 3" erythema on (R) thigh, minimal induration, non-tender, gait WNL (R) thigh circumference 12"; (L) thigh 11" circumference trmts cool compress/ibuprofen.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Local reaction, Tenderness
Clinical narrative: 5-9-13 C/O tenderness and warmth, ice and MOTRIN used. 5-10-13 3.5 inch circle of non-swollen redness, non-tender, slightly pruritic on (R) deltoid, 4.0 inch area on (L) (deltoid) arm, non-tender, slightly pruritic, Localized reaction bilaterally.
Age: 51.0
Sex: F
Vaccine: YF
Symptoms: Induration, Injection site rash, Tenderness
Clinical narrative: 6 inch oblong rash at injection site (sub q back of left arm), hard to touch and tender.
Age: 1.01
Sex: M
Vaccine: MEN, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Hot, hard red lump inder imjection site.  Baby has tun low fever.  Administered Tylenol.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Injection site pain, Muscle spasms, Pain in extremity
Clinical narrative: Pain at injection site, fatigue, muscle cramps, and aching in legs especially with exertion. States is typically a daily runner, but has not had the energy or been able to endure the aches.
Age: 1.31
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Lethargy, Poor quality sleep, Pyrexia
Clinical narrative: There seemed to be a slight fever for two nights, restless sleep, then woke up on May 4, 2013 with a 102 fever and very lethargic and fussy, went to the doctor that day, rash (small raised bumps) appeared on face and belly on Thursday May 8, rash on back of neck, May 9   decrease in appetite for most of week since fever started.
Age: 1.31
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: There seemed to be a slight fever for two nights, restless sleep, then woke up on May 4, 2013 with a 102 fever and very lethargic and fussy, went to the doctor that day, rash (small raised bumps) appeared on face and belly on Thursday May 8, rash on back of neck, May 9   decrease in appetite for most of week since fever started.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Skin mass
Clinical narrative: Redness, itching swelling, hot to touch surrounding injection site...large lump beneath skin area initially approximate 3 inches x 5 inches, on 051013--area 3 inches x 4 inches.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Skin warm, Swelling
Clinical narrative: Case number PHEH2013US010146, is an initial spontaneous report received from a health care professional on 03 May 2013. This report refers to a 10-year-old female patient. Her past medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: X11047, A11047) intramuscularly on an unspecified date. On 16 Jul 2012, she experienced raised, warm to touch, softball size. On an unspecified date, she developed cellulitis. She went to emergency rescue. She was treated with antibiotics for cellulitis. Outcome, seriousness and causality of event were not reported.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old male patient. No medical history and current conditions were reported. On 11-APR-2013, the patient was vaccinated with PNEUMOVAX 23 injection 25/0.5 ml single dose, subcutaneous (lot # H015749, exp 08-JUN-2014). No co suspects or concomitant medications were reported. On 11-APR-2013, the patient experienced muscle weakness and joint pain within 48 hours of receiving PNEUMOVAX 23. The patient was scheduled for a follow up appointment with the physician. At the time of the report muscle weakness and joint pain were not recovered. The primary reporter considered muscle weakness and joint pain to be significant disability. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Vaccine given on 4-19-13. Presented to clinic on 4-22-13 with rash all over body Measle like as per doctors note. On (4-22-13).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: 5/9/13 Redness and a little puffy, no fever. Red down to elbow (L) arm. 5/10/13 Redness extends down to (L) forearm now, warm to touch, no fever, no streaking, no pain, no discharge, still puffy, skin feels tight. Has full ROM. Tx: Ice to site, MOTRIN q 6-8 hours. Monitor temp.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Swelling
Clinical narrative: 5/9/13 Redness and a little puffy, no fever. Red down to elbow (L) arm. 5/10/13 Redness extends down to (L) forearm now, warm to touch, no fever, no streaking, no pain, no discharge, still puffy, skin feels tight. Has full ROM. Tx: Ice to site, MOTRIN q 6-8 hours. Monitor temp.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Red, warm, swollen.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, warm, itchy red.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
Clinical narrative: Vesicular patch w surrounding erythema (R) shoulder 8 cm.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Above person given Tdap booster in left arm on 5/8/13. Within 24 hours developed swelling, pain, redness, warmth, itching at injection site extending down to left elbow area. No fever. Treated with CLARITIN daily and KEFLEX x10 days.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Headache, Pyrexia
Clinical narrative: Pt given Td 5/9; called 5/10 to report fever > 101, and headache overnight.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient came to our pharmacy for Meningitis shot and we did not realized that the vaccine was expired until patient was given the shot. Patient condition is "fine, OK" and no reaction.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt developed redness, swelling at injection site on (L) ant thigh after immunizations given on 5/7/13. Had low grade fever on day 1.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Agitation, Anxiety, Feeling jittery, Pruritus
Clinical narrative: Itching - started nose, then forehead, jaw, neck, chest. Also sense of agitation. Itchy scalp. Jittery, anxious.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom states that pt's injection sites became red and swollen after they arrived home on 5/8/13 at 6PM. The areas increased in size since then. Parents were instructed to give pt CLARITIN, Ibu, and cold compress at his appt. today w/ Dr.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Vaccination complication
Clinical narrative: Has rash at site of recent injection. Received MMR, varicella, hep a in (L) Leg 4/22/13. Lot fussy, no other rash, no fever or other sx. Acting fine. Fluids, voids, activity nl. Current mediations, allergie, problems list reviewed. PE: Gen nl, nad alert, happy. Skin: 1 cm erythematous raised area (L) posterior thigh A/Immunization reaction, likely due to varicella or MMR P/Discussed, observe. Follow up if develops signs of injection. Like varicella vaccine reaction.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Likely varicella vaccine related. 12 m/o who had a reaction to his vaccines on his leg, area became red, swollen, and itchy. Received MMR, varicella, and hep A in L leg on April 4. Reaction started about 2 wks ago. No fever, no rash. Currently the area looks better but remains itchy. Pt. scratches the area whenever it is exposed. Otherwise feels well.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: MMR versus varicella reaction.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Irritability
Clinical narrative: Likely varicella vaccine related. Hx: 12 m/o here for symptoms of a rash with started with a bump on her leg on April 19, by the next day the bump was larger, and then the rash began spreading. Other lesiosn are not as large. No fever, no itchinig, eating up and down for some time and has not changed. Does seem crankier than nl. Mom is in the last trimester of pregnancy and states she has chicken pox; she has had a fever to 101 for the past two days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might have vaccinated with a dose of VARIVAX (Merck) (lot# not reported stored as high as 9F for about 2 months. No adverse effect reported. This is one of several assistant from same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) concerning a patient of unknown age and gender. On 03-MAY-2013 the patient was vaccinated with MMR II thimerosal containing (lot # 670087/0399AA, expiration date 16-MAR-2013) (dose, route and anatomical location unspecified). No concomitant medications were reported. On 03-MAY-2013, the patient was vaccinated by another healthcare worker (certified medical assistant) with an expired dose with MMR II. No adverse effect was reported. This is one of the two reports from the same source (1305USA002787). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The nurse reported that the patient was vaccinated with the 1st dose of GARDASIL (lot # not reported) 0.5 ml, intramuscular on 19-NOV-2012, the 2nd dose was administered on 13-DEC-2012 and the 3rd dose was administered on 31-JAN-2013. No adverse effects reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to a male patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On 05/02/2013 at 12:30 PM, the reporter stated that a patient received ZOSTAVAX vial 19400 plaque-forming units (PFU) (frequency, therapy rout Lot number and expiration date were not reported) on an unspecified date and developed "redness of the arm after receiving the shot that lasted about a day". Treatment and laboratories diagnostics neither were not reported. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old male patient. Healthcare worker reported that approximately on 30-APR-2013 the patient was vaccinated with first dose of GARDASIL (lot # and expiration date unspecified) injection, (dose, route and anatomical location unspecified) for vaccination. Healthcare worker reported that on 30-APR-2013 the patient complained of being very tired 15 minutes after receiving the first dose of GARDASIL last week. The patient went to an emergency room and was released without finding the cause. The patient went to a different emergency room and was released still without finding the cause. The patient went home and planned to see a neurologist. At the time of the report the outcome of tiredness was reported as not recovered. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased eye contact, Developmental delay, Fatigue, Fluid intake reduced, Hypophagia
Clinical narrative: My son suddenly became tired and went to sleep at the park. He developed a 105 fever which lasted 4 days, even when treated every 6-8 hours with Tylenol. He was lethargic and only ate and drank tiny amounts during this time. The advice nurse told me over the phone to put him in a short sleeve onesie and give Tylenol every 6 hours until it broke. Since then, his language regressed, all his milestones have been delayed, he stopped responding to his name and making eye contact for a year. When I saw his doctor 3 months later I was told these are normal side effects and are not worthy of reporting. After over a year, I still feel strongly this was an adverse event that has affected him despite the doctors casual attitude.
Age: 1.01
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Lethargy, Pyrexia, Speech disorder developmental, Unresponsive to stimuli
Clinical narrative: My son suddenly became tired and went to sleep at the park. He developed a 105 fever which lasted 4 days, even when treated every 6-8 hours with Tylenol. He was lethargic and only ate and drank tiny amounts during this time. The advice nurse told me over the phone to put him in a short sleeve onesie and give Tylenol every 6 hours until it broke. Since then, his language regressed, all his milestones have been delayed, he stopped responding to his name and making eye contact for a year. When I saw his doctor 3 months later I was told these are normal side effects and are not worthy of reporting. After over a year, I still feel strongly this was an adverse event that has affected him despite the doctors casual attitude.
Age: 1.29
Sex: M
Vaccine: HIBV, MNQ, VARCEL
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: As mentioned in the chicken pox vaccine information sheet we received, he had swelling around the area where the shot was given.  This persisted and got worse for more than three weeks, growing to the size of a quarter with the appearance of a spider bite.  The swelling is now gone, but a bruise/mark on the location still remains as of 5/11/13.
Age: 1.64
Sex: M
Vaccine: HEPA
Symptoms: Emotional distress, Erythema, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: His back turned red hot, started running a fever of 101.7 it climbed to 104.0 at one point. Gave him infants Tylenol every 4 hours fever came down to 100.6 then finally broke at midnite on May 9, 2013.  On May 11, 2013 he woke up with a red rash all over his body.  During all of this he would scream like he was being hurt, would not let anyone comfort him.  He was given water and juice because he would not eat anything.
Age: 1.64
Sex: M
Vaccine: HEPA
Symptoms: Screaming, Skin warm
Clinical narrative: His back turned red hot, started running a fever of 101.7 it climbed to 104.0 at one point. Gave him infants Tylenol every 4 hours fever came down to 100.6 then finally broke at midnite on May 9, 2013.  On May 11, 2013 he woke up with a red rash all over his body.  During all of this he would scream like he was being hurt, would not let anyone comfort him.  He was given water and juice because he would not eat anything.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Pyrexia, Urticaria, Vomiting
Clinical narrative: Fever, vomiting, hives, weakness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient reported redness around injection site 2 inches in diameter that appeared the day after injection. She has been diagnosed by physician with cellulitis and is currently on her second course of antibiotics and topical therapy. As of 5/11/13, she still reports that her condition has not resolved.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Hypersomnia, Rash, Vomiting
Clinical narrative: Throw up, rash, sleeping excessively, 05/10/2013-5/11/2013 2:00pm-8:00pm.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Headache
Clinical narrative: Headache experienced in the left top portion of the head and behind left eye. He felt a lot of pressure with pulsating feeling. Total of 3 episodes. 1st: around 7pm (same day of receiving vaccine 5/7/13), pain number of 7-8 out of 10. Took 2 tablets ibuprofen, no improvement, took another 2 tablets at 9am and headache went away. Was a gradual onset. 2nd: next morning (5/8/13). Sudden onset. Pain number 6 out of 10, took ibuprofen 2 tables, lasted 2 hours. 3rd: evening of 5/8/13, sudden onset. Pain number 2-3 out of 10, ate something and took ibuprofen 2 tablets, lasted about 30 minutes.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Axillary pain, Groin pain, Headache, Pain, Pain in extremity
Clinical narrative: Headache - seeing "stars", legs painful and hurt to walk - inner legs painful. (L) underarm pain and swelling - minor groin pain.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling, Visual impairment
Clinical narrative: Headache - seeing "stars", legs painful and hurt to walk - inner legs painful. (L) underarm pain and swelling - minor groin pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm swelling (L) deltoid not painful. Developed within 24-48 hrs.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 08-MAY-2012 the patient was vaccinated with first dose of GARDASIL (0.5ml, intramuscular) (lot number unspecified0. The patient would receive her second dose of GARDASIL on the reporting day, on 06-MAY-2013. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, MMR, RAB, TYP, YF
Symptoms: Blister, Fatigue, Headache, Influenza virus test negative, Mucosal ulceration
Clinical narrative: Oral mucosa ulcerations and vesicles, Fever, fatigue, throat pain, myalgias, headache.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, MMR, RAB, TYP, YF
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Oral mucosa ulcerations and vesicles, Fever, fatigue, throat pain, myalgias, headache.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Dysphemia, Speech disorder
Clinical narrative: Fell asleep on stairs then unable to talk - started with severe stammering and stuttering which has not resolved. Physician notified. Now in speech therapy twice a week.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Oral herpes, Pain
Clinical narrative: I felt achy throughout my shift that night and then the next morning I woke up with a cold sore.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Zoster outbreak on face.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV
Symptoms: Drug administration error
Clinical narrative: Vaccine administered inccorrectly.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood test, Convulsion, Electroencephalogram, Irritability, Musculoskeletal stiffness
Clinical narrative: Was acting normal all day, but had fever and runny nose and was whiny.  Three minutes before the seizure, began to stare at a spot on the ceiling and wouldn't respond.  Then, began to shake and became completely stiff.  Called 911, ambulance came within 2 minutes.  The seizure(s) lasted for more than 1 hour, even after being administered 4 different medications in the ambulance and ER.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Was acting normal all day, but had fever and runny nose and was whiny.  Three minutes before the seizure, began to stare at a spot on the ceiling and wouldn't respond.  Then, began to shake and became completely stiff.  Called 911, ambulance came within 2 minutes.  The seizure(s) lasted for more than 1 hour, even after being administered 4 different medications in the ambulance and ER.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Whole body scan
Clinical narrative: Was acting normal all day, but had fever and runny nose and was whiny.  Three minutes before the seizure, began to stare at a spot on the ceiling and wouldn't respond.  Then, began to shake and became completely stiff.  Called 911, ambulance came within 2 minutes.  The seizure(s) lasted for more than 1 hour, even after being administered 4 different medications in the ambulance and ER.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral, Rash pustular
Clinical narrative: Pt. developed cellulitis (left upper arm redness, warmth, swelling (size of softball), red and black pustules. Treatment: BACTRIM DS: 1 bid #14 tabs, VALTREX 1 gm: 1 tid #14 tablets.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Pt. has a warm circle at injection site and a rash spreading on her underarm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and sex who was one of the totally 9 patients. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and RECOMBIVAX, 5mcg/0.5ml, (Lot Number: 0384AE, exp: 02-NOV-2014 and Lot number: 0293AE, exp: 01-SEP-2014) was then, administered to 9 patients over a period of eight weeks (unspecified date in 2012). This patient was one of 9 patients who was involved in this AE with RECOMBIVAX HB (improperly stored RECOMBIVAX administered). The patient received 5 doses of RECOMBIVAX HB total. This occurred because 2 doses of the RECOMBIVAX HB the patient had received were improperly stored so they were readministered. Dose 1 was administered 23-OCT-2011 (this dose was improperly stored and administered by a different healthcare provider at a different facility, details of the temperature excursion are unspecified). Dose 2 was administered 21-NOV-2011. Dose 3 was administered 09-MAY-2012. Dose 4 was administered 03-DEC-2012 (this dose was improperly stored and administered by nurse). Dose 5 was administered 07-FEB-2013. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Patient's outcomes were unknown. This is one of several reports from the same source. The nurse stated that they were in the process of revaccinating approximately 275 patients. She was not aware of any adverse event being reported. Additional information is not available.
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. "Early this week", in April 2013 the patient was vaccinated subcutaneously with 0.65 ZOSTAVAX (lot # not reported) at the pharmacy. It was reported that the patient experienced swelling in an unspecified arm after receiving ZOSTAVAX. The outcome of swelling in an unspecified arm was reported as not recovered/not resolved. It was unspecified whether the patient sought medical attention. Additional information has been requested.