chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Vaginal lesion
Clinical narrative: This spontaneous report was received from a mother concerning her daughter of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient received a dose of GARDASIL, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. After vaccination, few days later, the patient developed lesions in or around her vagina. At the time of the report, the patient's outcome was unknown. The relatedness between suspect product and adverse event was not provided. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 50 year old female patient with an allergy to codeine and morphine who on 31-JUL-2013 was vaccinated with a dose of ZOSTAVAX (Lot No. H024045, exp. 14-FEB-2014) vial 19400 PFU subcutaneous. The patient reported to be on "a few" concomitant medications. It was reported that on an unknown date the patient visited the pharmacy due she developed an injection site section 4 inches in diameter that was red, itchy and patient described it as "felt like I've been stung by a bee". No lab diagnostic tests were performed. The pharmacist recommended BENADRYL and ice. Developed an injection site section 4 inches in diameter that was itching. At the time of the report the patient was recovering from the events.  Relationship between the reported events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient (demographics unknown), who on an unspecified date was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not provided). It was reported that, on an unknown date, the patient experienced pain and "swelling" at the injection site after receiving PNEUMOVAX23. The outcome for pain and "swelling" at the injection site was unknown. Relatedness for pain and "swelling" at the injection site was not reported for PNEUMOVAX23. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to 74 year old female patient. On 28-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H021710, expiration date 07-MAR-2014, (dose not reported) subcutaneous in the left arm. On an approximately 30-MAY-2013, approximately 2 days post vaccination the patient experienced a rash on the left side of her neck and rash on her left upper torso. The patient came into the pharmacy and then followed up with her physician. The patient was treated with steroid injections (unspecified date0. The outcome of rash on the left side of her neck and rash on her upper torso was unknown. The relatedness between event and ZOSTAVAX was not reported. This case is linked with case MARRS # 1308USA001724, concerning the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself. On 23-JUL-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot number and exp. date were not reported), 0.65 ml/once subcutaneous, for prevention. Concomitant medications were not reported. On 24-JUL-2013, patient experienced redness in area of ZOSTAVAX injection site. Patient reported no "blistering" and that the injection site "seemed to be getting lighter". Patient did not seek medical attention, and did not receive treatment for the adverse events. The outcome of experienced redness in area of ZOSTAVAX injection site and injection site seemed to be getting lighter was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-SEP-2011 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot number was not reported). The patient received the second, the third and the fourth dose of GARDASIL on 10-JUL-2012, 17-AUG-2012, 24-MAY-2013 respectively (strength, doses, routes and lot numbers were not reported). No adverse effects was reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Redness and swelling at site. Fever 101.1. Nausea, vomiting, diarrhea. Apply cool compress to site, Ibuprofen for inflammation and fever.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Redness and swelling at site. Fever 101.1. Nausea, vomiting, diarrhea. Apply cool compress to site, Ibuprofen for inflammation and fever.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Redness/swelling/heat from shoulder to elbow. Started BACTRIM DS in the event that it is cellulitis. Started prednisone orally in the event that it is a reaction.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Patient reported onset of swelling, redness and pain in left upper arm. The erythema measured 11cm x 15 cm and the induration measured 4 cm x 7 cm.  This area of erythema and induration was significantly distal to the injection site in the left deltoid.
Age: 15.0
Sex: M
Vaccine: HEPA, HIBV, HPV4, MMR
Symptoms: Blister, Measles
Clinical narrative: Broke out in blisters + has measles.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Increased redness, swelling, and pain around injection site.  Pt went to ER and was diagnosed with cellulitis.  Antibiotic was prescribed.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Hypoaesthesia teeth, Pruritus generalised
Clinical narrative: TEETH FELT NUMB, BODY VERY ITCHY AND DIARRHEA.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Gait disturbance, Injection site movement impairment, Muscle twitching, Pain
Clinical narrative: Woke up and couldn't walk on his leg where he received the vaccine. We had to hold him all morning and mid afternoon. He started walking on his leg after his nap but was painfully limping. He also has lost appetite in the morning. There was also twitching of his legs and arms. The next day (07/28) he was walking but still limping and a rash appeared on his thigh. The third day he could walk fine and the rash lasted 2 more days.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Woke up and couldn't walk on his leg where he received the vaccine. We had to hold him all morning and mid afternoon. He started walking on his leg after his nap but was painfully limping. He also has lost appetite in the morning. There was also twitching of his legs and arms. The next day (07/28) he was walking but still limping and a rash appeared on his thigh. The third day he could walk fine and the rash lasted 2 more days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Rash generalised
Clinical narrative: Sore arm at injection site; light rash all over body that continued (so far) for two days.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Leukocytosis, Pyrexia, Tenderness
Clinical narrative: Significant (8cmm) erythema, induration and tenderness; fevers to 102, leukocytosis (20).
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Ultrasound scan normal, White blood cell count increased
Clinical narrative: Significant (8cmm) erythema, induration and tenderness; fevers to 102, leukocytosis (20).
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Significant (8cmm) erythema, induration and tenderness; fevers to 102, leukocytosis (20).
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Leukocytosis
Clinical narrative: Significant (8cmm) erythema, induration and tenderness; fevers to 102, leukocytosis (20).
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Leukocytosis, Pyrexia, Tenderness
Clinical narrative: Temperature to 101. Injection site induration, warmth, and tenderness. Leukocytosis. Possible cellulitis given spreading erythema.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Ultrasound scan normal, White blood cell count increased
Clinical narrative: Temperature to 101. Injection site induration, warmth, and tenderness. Leukocytosis. Possible cellulitis given spreading erythema.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Temperature to 101. Injection site induration, warmth, and tenderness. Leukocytosis. Possible cellulitis given spreading erythema.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Leukocytosis
Clinical narrative: Temperature to 101. Injection site induration, warmth, and tenderness. Leukocytosis. Possible cellulitis given spreading erythema.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Laceration, Product quality issue
Clinical narrative: This spontaneous report is received from a 32 year old female healthcare worker referring herself. No medical history and drug allergies were reported. On 12-JUL-2013, the healthcare worker cut her finger on a broken VARIVAX (Merck) (Lot # H006462, exp. date: 08-MAR-2014). PQC filled for broken VARIVAX (Merck). The healthcare worker treated the cut "per office protocol". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-JUL-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot number 1224AA and expiration date 26-JUL-2013) (dose, frequency and route were not reported). Concomitant therapy was not reported. No adverse event effects reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Localised oedema, Presyncope, Vomiting
Clinical narrative: Local edema of the shoulder, dizziness, near fainting, headache, vomiting.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Caused 2" area of redness, swelling, and tenderness.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall
Clinical narrative: Patient had no signs and symptoms after having injections of any reactions during time of course when patient walked out side she fell to ground and ambulance was called.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain in left upper extremity near the injection site. Tx: TYLENOL, BENADRYL.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 48 hours after vaccine administration erythema 9 x 6 cm left upper arm (L) shoulder and upper arm (deltoid) pain. Improved after 48 hours w/discomfort. Swelling at site. Patient afebrile. Treatment: NSAIDS, TYLENOL for discomfort, elevate, cool compresses-call back with worsening symptoms which were reviewed.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Fatigue, Headache, Hyperhidrosis, Local swelling
Clinical narrative: Anthrax #5 July 31, 13. Swollen arm, tender, red, muscle aches, headaches, nausea, extreme fatigue, profuse periods of sweating, nausea.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Nausea, Tenderness
Clinical narrative: Anthrax #5 July 31, 13. Swollen arm, tender, red, muscle aches, headaches, nausea, extreme fatigue, profuse periods of sweating, nausea.
Age: 12.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness and swelling at site of HPV vaccine Redness, swelling, rash surrounding site of varicella vaccine.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Received vaccine in (R) deltoid. Began breaking out in a raised itchy rash on his (L) upper arm on 7/28/13. Spread to involve face, neck, arms, legs and back of hands (-spares palms and soles) over the next 5 days. Treated with BENADRYL and hydrocortisone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Local reaction; redness, itching, swelling.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever 102-103 chills sweats right arm pain, redness down to mid arm, swelling -lasted 5 days. Tx with ice, ADVIL.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Swelling
Clinical narrative: Fever 102-103 chills sweats right arm pain, redness down to mid arm, swelling -lasted 5 days. Tx with ice, ADVIL.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Hypersensitivity, Rash morbilliform, Urticaria
Clinical narrative: Hives. ER visit. Do not feel is related to shots but being cautious hydroxyzine. Patient has a rash of hives or urticaria. I suspect this may be an allergic reaction from his MMR or other vaccinations. Other possible causes could be a virus. Food or medicine. This is not the same I believe as an "MMR" reaction. Which usually occurs 7-10-14 days after an MMR. The rash in this instance is not hive like. And is a measle like rash. Moreover usually fever is a prominent component to this type of rash. This has not yet been the case with patient. ATARAX usually works better than BENADRYL and I would use it instead. He may have a dose every 6-8 hrs as need for the hive like rash. I would have him reevaluated by clinic on Monday. Return sooner to the ed if he worsens.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: After receiving the vaccine, the patient developed redness and swelling at injection site. The patient was seen by their PCP who prescribed a MEDROL dose pack and hydroxyzine.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt called 7/31 to report that area that she received a pneumo shot. She explained that area was red and painful and getting a bit larger than day before. I explained that this is a normal reaction - but since pt was leaving for trip - out of country - maybe should consult with MD.
Age: 16.0
Sex: F
Vaccine: HPV2, MNQ
Symptoms: Erythema, Injection site anaesthesia, Local swelling, Macule
Clinical narrative: Pt. developed numbness in the left arm above and below the shots for 20-30 mins with normal sensations in forearm. Also had mild swelling on arm and one erythematous 1 cm macule around elbow. Pt. rested, warm compresses, massage and BENADRYL all s.s resolve in 30 mins.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Confusional state, Loss of consciousness, Vision blurred
Clinical narrative: Passed out approx. 3 times with confusiion had episode of blurred vision, weak, symptoms worse, car ride from office to ER. Symptoms started on car ride home from office.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 45 min after immunization when patient returned home her arm started swelling turned red and is hot to the touch.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Tdap administered at 8:15 am pt. sat for 10 minutes, began walking became pale, sweaty, dizzy and fainted. Vitals taken 80/60 pulse 78 and 78/60 p.60. Pt taken to ED and monitored.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Pt became nauseous and dizzy 45 minutes after injection.
Age: 2.0
Sex: M
Vaccine: HEPA, PPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster diagnosis in a 1-dose varicella vaccine recipient.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Blood test, Cholecystectomy, Computerised tomogram
Clinical narrative: Violently vomiting, extreme nausea and abdominal pain.  After years of bloodwork, xrays, gall bladder removed.  Didn't help.  Now diagnosed with gastroparesis.  Had a pacemaker put in stomach March 2013.  Had to stop going to college because she is sick every 2 weeks and in and out of hospital.  Can work maybe 1-2 times a week.  Had to move home and now is on depression medication too.  My daughter was a very healthy happy outgoing child with big dreams.  She is now nothing like she was before the shots.  We are christians living in hell.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Endoscopy, Impaired gastric emptying, Laboratory test, Malaise
Clinical narrative: Violently vomiting, extreme nausea and abdominal pain.  After years of bloodwork, xrays, gall bladder removed.  Didn't help.  Now diagnosed with gastroparesis.  Had a pacemaker put in stomach March 2013.  Had to stop going to college because she is sick every 2 weeks and in and out of hospital.  Can work maybe 1-2 times a week.  Had to move home and now is on depression medication too.  My daughter was a very healthy happy outgoing child with big dreams.  She is now nothing like she was before the shots.  We are christians living in hell.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device implantation, Nausea, Nuclear magnetic resonance imaging, Vomiting, X-ray
Clinical narrative: Violently vomiting, extreme nausea and abdominal pain.  After years of bloodwork, xrays, gall bladder removed.  Didn't help.  Now diagnosed with gastroparesis.  Had a pacemaker put in stomach March 2013.  Had to stop going to college because she is sick every 2 weeks and in and out of hospital.  Can work maybe 1-2 times a week.  Had to move home and now is on depression medication too.  My daughter was a very healthy happy outgoing child with big dreams.  She is now nothing like she was before the shots.  We are christians living in hell.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray with contrast lower gastrointestinal tract, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Violently vomiting, extreme nausea and abdominal pain.  After years of bloodwork, xrays, gall bladder removed.  Didn't help.  Now diagnosed with gastroparesis.  Had a pacemaker put in stomach March 2013.  Had to stop going to college because she is sick every 2 weeks and in and out of hospital.  Can work maybe 1-2 times a week.  Had to move home and now is on depression medication too.  My daughter was a very healthy happy outgoing child with big dreams.  She is now nothing like she was before the shots.  We are christians living in hell.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Swollen tongue, Wheezing
Clinical narrative: Pt states felt funny after left clinic, then tongue started to swell, wheezing. Seen at PCP's office and was given Benadryl and steroids.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered adult formulation of Hepatitis A vaccine vs pediatric. Error of medical staff administering vaccine.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Felt dizzy after his HPV vaccine, put supine for 10 mins, walked to waiting room and still felt dizzy, had water and lollipops, BP taken=120/80, MD assessed pt before he left.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Injection site is red and swollen and a hard lump can be felt at the injection site.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient turned pale--complained of dizziness and passed out. I eased him to the floor, elevated his feet and legs, placed pillow under head and broke ammonia strip under his nose...he woke up. Observed him on the floor 10  minutes then eased him to sitting position...then up to chair. Walked him to the lobby...he walked out the door on his own with his sister and mother.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Received additional abx.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13, VARCEL
Symptoms: Abasia, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pts left leg from upper thigh down to the shin was red, swollen and hot to the touch.  The patient could not walk because of the pain from this.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Baseball sized firm spot on arm of injection and half dollar sized red itchy spot at site of injection as reported to us by MD office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Lt deltoid area erythemous 60 mm.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Rash, Skin warm
Clinical narrative: Swollen arm, red, hot to touch, rash around under arm and legs. Doctors refused to look at her. Had to find another doctor and was told in was an allergic reaction.
Age: 26.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Pruritus, Rash, Skin tightness, Swelling
Clinical narrative: Swelling, itching, tightness, erythema that has spread down the arm bordered by rash. Approximate measurement of red zone is 10cm by 8 cm and continues to spread around the arm. Day 2 of reaction worse than day 1.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Poor quality sleep, X-ray limb
Clinical narrative: Patient states on the evening of the 26th into the 27th she did not sleep well because of the pain in arm. When she woke up on the 27th she could not move arm more than 2" from body. She started w/ROM exercises. She continued to work but on Sunday 8/3/13 she went to an urgent care center and then had an OV at dr office on 8-6-13.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came in on 8/2/13 with c/o (R) thigh redness and swelling. Provider ordered BENADRYL 25 mg/10 ml. 5 ml PO a x 1 now. Rx prednisone 15 mg/5 ml 1 tsp PO once daily x 5 days.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's mother refers to her son of unknown age. In August 2012 the patient was vaccinated with his first dose of GARDASIL (exact date unspecified) (dose, route and lot number not provided) and did not receive his second dose until 02-AUG-2013. There were no adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of "older adolescent" patients of unspecified gender. On an unknown date the patients were vaccinated with the first dose of GARDASIL (lot numbers and expiration dates not reported) (dose and route not reported) for prophylaxis. The nurse reported that these patients had been off schedule with receiving their second doses of GARDASIL. The nurse reported the patients received their first doses of GARDASIL on unspecified dates and have returned to the office at various times on unspecified dates to receive their second doses after the second dose was due to be given. The reporter mentioned that the time between the first and second doses had often been a year and did not specify how many patients were involved. The nurse also stated some of these patients may had only received a two dose series of GARDASIL and did not receive all three doses. No adverse symptoms were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Client with sister and grandmother for GARDASIL an meningitis. Faints after-getting GARDASIL, which was second shot given on 8-5-13. Revives immediately. After monitoring vital signs for approx. 15-20 min. Client stable. Taken by grandmother to his PCP after leaving clinic site.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: According to physician, pt received ZOSTAVAX 7/18/13. He had injection site redness and pain which progressed over a weeks time into full-blown shingles, which the physician treated him for.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: According to physician, pt received ZOSTAVAX 7/18/13. He had injection site redness and pain which progressed over a weeks time into full-blown shingles, which the physician treated him for.
Age: 33.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lateral aspect of left upper arm reddened and raised. Area extends entire length and width of upper arm and is painful to the touch.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Immunizations were given at 3 pm. We asked pt to wait in waiting area for 15 min per VIS recommendation. Within 5 minutes pt was c/o light headedness, dizzy, pt appeared pale and clammy. Nurse practitioner examined pt. We gave him water and crackers to drink and eat. Pt feeling well after 25 minutes passed and left with mother.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Lt arm swelling, redness, warmth and pruritus x 2 day. Also low grade fever. Given Benadryl x 2. Given Pediapred 3 ml PO BID x 3 days, then BID PO x 2 days.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Middle insomnia, Mobility decreased
Clinical narrative: Pt got shot on 8/7 had some slight itching but no other problems. At about 5 pm 8/8 spot itched again woke up in the night site swelled up to egg size rash itchy could hardly move hand. Rash and itching has moved to include head and neck. Arm was painful went to ER 8/8-8/9.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Pt got shot on 8/7 had some slight itching but no other problems. At about 5 pm 8/8 spot itched again woke up in the night site swelled up to egg size rash itchy could hardly move hand. Rash and itching has moved to include head and neck. Arm was painful went to ER 8/8-8/9.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray normal, Convulsion, Laboratory test normal, Metabolic function test normal, Pyrexia
Clinical narrative: Fever, consulvion and staring spell.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Staring
Clinical narrative: Fever, consulvion and staring spell.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Vomiting
Clinical narrative: Vomited on Wednesday, 8/7/13. Severe body aches, red band/swelling almost entirely around injection site arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Skin discolouration
Clinical narrative: Pt had a 1/2 dollar size rash 2 days after shot with heat, redness, itching and tenderness. Next day when called pt said heat is gone down (no heat), no swelling just red with rash and itchy - pt comes back 4 days after saying it's blue and black.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pt had a 1/2 dollar size rash 2 days after shot with heat, redness, itching and tenderness. Next day when called pt said heat is gone down (no heat), no swelling just red with rash and itchy - pt comes back 4 days after saying it's blue and black.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Abdominal pain upper, Diarrhoea, Pruritus generalised, Pyrexia, Rash macular
Clinical narrative: Patient received vaccinations on 8/5/13. On 8/6 she woke up with a 102.5 degree fever, diarrhea, stomach and congestion. On 8/9 she woke up with a red blotchy rash that was itchy all over her upper body. No fever on 8/9.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Respiratory tract congestion
Clinical narrative: Patient received vaccinations on 8/5/13. On 8/6 she woke up with a 102.5 degree fever, diarrhea, stomach and congestion. On 8/9 she woke up with a red blotchy rash that was itchy all over her upper body. No fever on 8/9.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unknown number of patients of unknown age and gender. The nurse reported that an unknown number of patients were vaccinated with GARDASIL (lot number and expiration date not provided) (dose and route not provided), or VAQTA (lot number and expiration date not provided) (dose and route not provided), stored as low as 30F for an unknown number of times and for an unknown total amount of time. No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Dyspnoea, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. On 01-JUL-2013, reported as 6 weeks ago, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 02-JUL-2013, reported as 1 day post vaccination, the patient experienced trouble breathing and asthma and 4 days post vaccination, on 05-JUL-2013 the patient experienced urticaria. The patient went to the local emergency room but was not hospitalized and received an unspecified treatment. The outcome of trouble breathing, asthma and urticaria was reported as recovered and healthy. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional concerning a 1 year old patient of unknown gender. On 02-JUL-2013, the patient was vaccinated with a expired dose of M-M-R II (HSA) first dose, 0.5 ml, subcutaneously (lot #1025AA exp 30-JUN-2013). No adverse effects were reported. Additional information has been requested. This is one case of several cases reported by the same reporter.
Age: 1.26
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional concerning a 1 year old patient of unknown gender. On 05-JUL-2013, the patient was vaccinated with expired dose M-M-R II first dose, 0.5 ml, subcutaneously (lot # 1025AA exp 30-JUN-2013). No adverse effects were reported. Additional information has been requested. This is one case of several cases reported by the same reporter.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 9 year old patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (route and lot # not reported). On 08-JUL-2013, the patient experienced mild case of  chickenpox. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.9
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: This spontaneous report as received from a health care professional refers to a 10 month old male patient. On 04-JUN-2013, the patient's grandmother was vaccinated with a dose of ZOSTAVAX. On 29-JUN-2013, the patient broke out with chickenpox. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 01-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported) that was exposed to warmer temperature during shipment. No adverse effects were reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: On 8/7/13 - left deltoid, redness 3 1/2 cm by 4 cm, hard lump, swelling, no fever today. Felt warm. Treatment was iced pack to put on arm when needed.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Paraesthesia
Clinical narrative: PATIENT REPORTS LEFT ARM C-5 DERMATOME PARESTHESIA's AFTER INJECTION INTO LEFT DELTOID WITH 1st HAVRIX (LOT# AHAVB672AA ) & 2nd ENGERIX-B (LOT # AHBVCO64BB ) VACCINATIONS.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site reaction, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Received injection on top of shoulder and immediately felt a sensation in the shoulder joint.  Stiffness began later about 5:00 pm with pain and warmth of the outer skin.  Minor pain continued for a week.  Later I noticed that my range of motion deteriorated and I could no longer fasten my bra without causing tremendous pain.  Returned to the Dr. who referred me to an orthopedic surgeon who diagnosed frozen shoulder and recommended six weeks of physical therapy. Condition is worsening with limited range of motion and constant pain.  Had an injection of cortisone with no change.
Sex: F
Vaccine: VARZOS
Symptoms: Periarthritis, Skin warm, X-ray
Clinical narrative: Received injection on top of shoulder and immediately felt a sensation in the shoulder joint.  Stiffness began later about 5:00 pm with pain and warmth of the outer skin.  Minor pain continued for a week.  Later I noticed that my range of motion deteriorated and I could no longer fasten my bra without causing tremendous pain.  Returned to the Dr. who referred me to an orthopedic surgeon who diagnosed frozen shoulder and recommended six weeks of physical therapy. Condition is worsening with limited range of motion and constant pain.  Had an injection of cortisone with no change.
Age: 1.06
Sex: F
Vaccine: HIBV, MMRV, PPV
Symptoms: Fatigue, Irritability, Rash generalised, Rash maculo-papular, Rash vesicular
Clinical narrative: Initially noticed <5 small maculo-papular vs. vesicular lesions on forehead, these spread to behind ears, down her face to neck and then trunk and entire body.  They were not extremely erythematous.  Temperature was not taken but felt febrile, was fatigued, fussy, and sleepy.
Age: 1.06
Sex: F
Vaccine: HIBV, MMRV, PPV
Symptoms: Somnolence
Clinical narrative: Initially noticed <5 small maculo-papular vs. vesicular lesions on forehead, these spread to behind ears, down her face to neck and then trunk and entire body.  They were not extremely erythematous.  Temperature was not taken but felt febrile, was fatigued, fussy, and sleepy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Pt noted small area of redness adjacent to vaccination site. Gradually spread over the following day and sought medical care on 8/10. At time of evaluation found to have a confluent path of erythema and induration along posterior aspect of L upper arm. (+) warm, not tender. Reportedly was mildly itchy. No blisters or vesicles noted. Temp was 99.8 in office but no fever or chills reported. Pt felt otherwise well. Treating as allergic reaction but if any progression will treat for infection.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt noted small area of redness adjacent to vaccination site. Gradually spread over the following day and sought medical care on 8/10. At time of evaluation found to have a confluent path of erythema and induration along posterior aspect of L upper arm. (+) warm, not tender. Reportedly was mildly itchy. No blisters or vesicles noted. Temp was 99.8 in office but no fever or chills reported. Pt felt otherwise well. Treating as allergic reaction but if any progression will treat for infection.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Pt noted small area of redness adjacent to vaccination site. Gradually spread over the following day and sought medical care on 8/10. At time of evaluation found to have a confluent path of erythema and induration along posterior aspect of L upper arm. (+) warm, not tender. Reportedly was mildly itchy. No blisters or vesicles noted. Temp was 99.8 in office but no fever or chills reported. Pt felt otherwise well. Treating as allergic reaction but if any progression will treat for infection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Hypersensitivity, Pharyngeal oedema
Clinical narrative: Was eating at restaurant that evening and had allergic reaction with trouble breathing/throat swelling. Had been eating carrots; had never had a reaction to this food before but has continued to react ever since then; Epi Pen was administered; patient went to nearest ER and was treated there. Do not information from that ER visit.
Age: 0.81
Sex: F
Vaccine: FLUX
Symptoms: Cough, Irritability, Rash generalised, Urticaria
Clinical narrative: Full body rash/hives, irritability, minor cough.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Tearfulness, Tremor, Unresponsive to stimuli
Clinical narrative: During checkout after appt, patient leaned against the wall and slumped down, with approx 5-10 seconds of shaking. She was assisted to the floor, where she was unresponsive for approximately 1 minute. Upon regaining consciousness, she was tearful and rather quiet. She was allowed to rest on the floor an additional 2 minutes, then returned to the exam room, where she was observed for another 20 minutes, after which time she was alert and oriented, with stable vital signs, taking PO well.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: VIIth nerve paralysis
Clinical narrative: Developed right Bell's Palsy 3 days after the vaccinations. The patient had developed right viral conjunctivitis 2 days prior to the vaccines and had the braces for her teeth tightened the day after the vaccines.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Ataxia, Muscle enzyme, Nerve conduction studies
Clinical narrative: Patient that at 48hrs post-vaccination presented ataxia, without loss of strength or reflex. Patient monitored, the muscular enzymes not presented positive in increments. Progression resolved without sequel. The following letter is to inform you of the effects my son experienced after being vaccinated. The child was vaccinated on July 29 2013, the day after the vaccination the child experienced high fevers, difficulty walking, strong pain in the neck, lower back, loss of appetite and strong headaches. These symptoms persisted for a period of 6 consecutive days. Like any mother worried for my son's health I took him to his pediatrician who ran some lab tests to verify the health of the child; the results indicated that it was something viral. But I was worried since he had never experienced such severe problems after a vaccine, only the normal low fever which did not last for more than a day and a half. The moment the vaccines were administered I did not receive any information about vaccine adverse events, I found this information via internet since I was so worried. A person worried about my son provided me the information so that I could have it handy and read it and learn more about these vaccines. I took him to the health center where they specified again that the boy had something viral and a strong inflammation on his muscles that is why he had problems walking. They let me know that it was not a vaccine reaction but I had doubts since his health worsened greatly the days after the vaccines (HPV, MCV, TDAP) were administered.
Age: 1.0
Sex: M
Vaccine: HEPA, IPV, MMRV
Symptoms: Dermatitis allergic
Clinical narrative: Severe skin reaction after given PROQUAD, IPOL, and HAVRIX; given BENADRYL for the allergic reaction and patient respond well to it
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a registered nurse concerning a 68 year-old male patient with "sulfa drugs" allergy (the patient noted that, on an unknown date, the head of his penis turned blue and swelled). On 17-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot # J002777, expiry date 07-JUN-2014 (dose not provided). It was reported that, on 19-JUL-2013, the nurse noted that the patient developed a "fever blister on his lip". The patient saw an unspecified physician about the fever blister on his lip persisted. Relatedness for fever blister on his lip was not reported for ZOSTAVAX. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 25 years old female patient with no pertinent medical history and no drug allergies. On an unknown date in August 2012 (reported as sometime at the end of August 2012, which was four to five weeks before the patient became pregnant), the patient was vaccinated with a dose of M-M-R II (Lot number, expiry date and dose were not reported). Concomitant medications included: vitamins (unspecified) (Prenatal vitamins). Subsequently, the patient became pregnant (first pregnancy) with a last menstrual period (LMP) of 21-SEP-2012 and an estimated date of delivery (EDD) of 28-JUN-2013. The patient was exposed to M-M-R II during trimester 1 and 2. None of the laboratory test was performed. At the time of the report the patient was about 19 weeks pregnant. The patient sought medical attention (had called the reporting pharmacist). The outcome of pregnancy was unknown (outcome pending). Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: I had no pain at time of injection on 8/5 or even the day after (8/6). I woke up on 8/7 with pain deep in my shoulder and it was painful to move my arm overhead. By the next day, the pain had worsened and since then I have been unable to move my arm behind my back.  As of today (8/11), in addition to the shoulder pain, I now have pain radiating up my neck on the same side as the injection site.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Pin point rash over entire body.
Age: 20.0
Sex: F
Vaccine: HPV4, IPV, MNQ, PPV, TDAP
Symptoms: Cellulitis, Erythema, Injection site swelling, Pain in extremity, Skin discolouration
Clinical narrative: Patient reported pain and redness to left arm starting about 9PM which progressed to swelling of the upper arm and the entire arm turning purple. Patient was seen in the ER on 7/10/13 at Medical Center for another problem, but it was noted at that time that she either had a reaction to the vaccines vs cellulitis of her left arm. Patient was given Cephalexin for 10 days and Benadryl.
Age: 20.0
Sex: F
Vaccine: HPV4, IPV, MNQ, PPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: Patient reported pain and redness to left arm starting about 9PM which progressed to swelling of the upper arm and the entire arm turning purple. Patient was seen in the ER on 7/10/13 at Medical Center for another problem, but it was noted at that time that she either had a reaction to the vaccines vs cellulitis of her left arm. Patient was given Cephalexin for 10 days and Benadryl.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccine site right deltoid, then became more swollen with bulleye appearance.  Approx. 6cm in diameter with induration especially in center of area.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Back pain, Biopsy, Blood test
Clinical narrative: Hair loss, stomach pains, back pains, nausea, dizziness.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Ultrasound abdomen
Clinical narrative: Hair loss, stomach pains, back pains, nausea, dizziness.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Lace-like urticaric rash anterior thighs, progressing to full torso and thighs over 48 hours until presentation in clinic.
Age: 33.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen, hot, raised area around injection site. Approximately 2 inches in diameter.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Granuloma annulare, Oral lichen planus
Clinical narrative: Diagnosed with oral lichen planus and annulare granuloma.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Lacrimation increased, Pruritus, Wheezing
Clinical narrative: Allergic - watery eyes, itching, coughing, wheezing. Treated with prednisone.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient showed mild redness on site on 8/10/13 redness to pharmacy 8/11/13 at 9:00 am with mild fever and 4-5 inch reaction redness hot to touch. Patient was going to ER for further workup.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 73 years old patient of unknown gender. On 15-JUL-2013 the patient was inadvertently vaccinated with an expired 0.65 ml dose of ZOSTAVAX (lot # 0618AE, expiration date: 23-JUN-2013), subcutaneously at unspecified locations. No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Age: 83.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a now 83 year old patient. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number, strength, dose, route and site unspecified) instead of ZOSTAVAX due to a human error. It was unspecified if the patient had sought medical attention. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a now 63 year old patient. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number, strength, dose, route and site unspecified) instead of ZOSTAVAX due to a human error. It was unspecified if the patient had sought medical attention. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.