chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 22-JUL-2014 the patient was vaccinated with M-M-R II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 14 month old patient. On 08-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. Activity date reported as 14-JUL-2014. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 08-AUG-2014 the patient was vaccinated with M-M-R II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Smallpox
Clinical narrative: This case was received on 27 August 2014 via a third party query tool search on the VAERS database, under reference number 530170. A 19 year-old male patient had received the following vaccines on 25 April 2014, a left arm injection of ACAM2000 (lot number VV04003A), an intramuscular right arm injection of TYPHIM VI, lot number J1629 and an intramuscular right arm injection of BIOTHRAX (lot number FAV365A) and nine days later on 04 May 2014, was found to have a secondary smallpox lesion on the right forearm. The patient was seen in the emergency room. Treatments were not reported. Current illnesses were none. Other medications, history, lab data and prior vaccinations were not reported. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Anxiety, Gait disturbance, Hemiplegia, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative and a nurse refers to a 11 year old female patient with asthma, common season allergies and cephalexin allergy. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number# not provided). Concomitant therapy included unspecified allergy and asthma medication. The patient immediately started feeling tingling in her face as well as pressure in her face on 18-AUG-2014. The patient was kept in the physician's office for 30 minutes after the GARDASIL was administered for observation. The patient experienced "paralysis on the side of her body and was unable to walk, dragging her one leg." The patient was taken to an unspecified emergency room and was released, without admission to the hospital, with a diagnosis of anxiety. Patient was fully recovered on an unspecified date in August 2014. Upon internal review, "feeling tingling in her face as well as pressure in her face, paralysis on one side of her body and was unable to walk, dragging her one leg, diagnosis of anxiety" was considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Sensation of pressure
Clinical narrative: This spontaneous report as received from a physician via a company representative and a nurse refers to a 11 year old female patient with asthma, common season allergies and cephalexin allergy. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number# not provided). Concomitant therapy included unspecified allergy and asthma medication. The patient immediately started feeling tingling in her face as well as pressure in her face on 18-AUG-2014. The patient was kept in the physician's office for 30 minutes after the GARDASIL was administered for observation. The patient experienced "paralysis on the side of her body and was unable to walk, dragging her one leg." The patient was taken to an unspecified emergency room and was released, without admission to the hospital, with a diagnosis of anxiety. Patient was fully recovered on an unspecified date in August 2014. Upon internal review, "feeling tingling in her face as well as pressure in her face, paralysis on one side of her body and was unable to walk, dragging her one leg, diagnosis of anxiety" was considered to be medically significant. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Erythema, Feeling hot, Injection site pain, Pain in extremity
Clinical narrative: Entire left arm sore, face was hot and red.  Felt dizzy.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Lymph node palpable
Clinical narrative: Palpable lymph node (B) in left post. occipital chain, <1 cm size - nontender, no redness or warmth; canker sores in mouth.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: Starting evening of shot (approximately 6 hours later) tingling in arm from inj site to fingers. Swelling of arm at inj site and surrounding areas. As of 9 AM 9/3/14 tingling still from inj site to wrist. No fingers. Swelling better. Ice, BENADRYL.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rashes around collar bone and partially on right shoulder. Intensive itch on left side of collar bone.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Pt's daughter called around 7:00 PM saying patient had chills and shivering, and temp. 99 degrees F.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Influenza like illness, Local swelling, Malaise, Pain
Clinical narrative: Swollen right arm. Pt had red hot rash. Pain to touch. Describes her pain very severe unbearable that she almost went to ER. Rash about 1 1/2 in., felt sick, headache, flu like. Had 2 separate vaccines on different arms the arm where she had PNEUMOVAX she complained.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Swollen right arm. Pt had red hot rash. Pain to touch. Describes her pain very severe unbearable that she almost went to ER. Rash about 1 1/2 in., felt sick, headache, flu like. Had 2 separate vaccines on different arms the arm where she had PNEUMOVAX she complained.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 25-AUG-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot number J001698 with expiry date 08-MAY-2014. ZOSTAVAX was expired on 08-MAY-2014. Nurse stated the ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approximately 10 minutes after injection, a dime-sized raised area appeared to the right of the injection site (on the left leg); slight redness around the raised area seen.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Paraesthesia oral
Clinical narrative: 15 minutes after vaccination, pt mentioned to receptionist that her tongue "feels funny".  States it feels "like right before you throw up".  No shortness of breath or breathing difficulty.  BP-148/100, P-60, regular.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Migraine, Nausea, Pyrexia
Clinical narrative: DIZZINESS; NAUSEA; FEVERISH FEELING (TEMP NOT MEASURED); MINOR DIARRHEA; ONSET OF MIGRAINE HEADACHE, MINOR VISION DISTURBANCES.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: DIZZINESS; NAUSEA; FEVERISH FEELING (TEMP NOT MEASURED); MINOR DIARRHEA; ONSET OF MIGRAINE HEADACHE, MINOR VISION DISTURBANCES.
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately s/p vaccination, pt c/o dizziness. Put to lie supine on exam table, after 15 mins dizziness resolved.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: 101 degree fever within 12 hours of receiving the first MMR vaccine.  Fever spiked again 6 hours after first fever subsided.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Foreign body sensation in eyes, Glossodynia
Clinical narrative: Felt "like sand in my eyes", soreness under tongue, cough, chills, sweats, tired, heavy breathing.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hyperventilation
Clinical narrative: Felt "like sand in my eyes", soreness under tongue, cough, chills, sweats, tired, heavy breathing.
Age: 16.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Muscle rigidity, Musculoskeletal stiffness, Nausea
Clinical narrative: Client received 2nd Varicella shot and Tdap shot. 2 minutes after Tdap client had rigid stiffening of body lasting 30 seconds followed by diaphoresis, nausea, pallor, and feeling faint. No rash or breathing/swallowing difficulty.
Age: 16.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Pallor
Clinical narrative: Client received 2nd Varicella shot and Tdap shot. 2 minutes after Tdap client had rigid stiffening of body lasting 30 seconds followed by diaphoresis, nausea, pallor, and feeling faint. No rash or breathing/swallowing difficulty.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Infection, Local reaction, Pain
Clinical narrative: Redness and pain-- radiating to severe local reaction.  MD diagnosed as an infection and is treating her with Cephalexin 500mg one capsule three times a day.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Flu vaccine was administered and arm very, very sore where shot entered.  Actually, the whole arm is sore--two days later.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Malaise, Vomiting
Clinical narrative: Mother reports that roughly 30 minutes after injection they were traveling in car and he vomited a small amount and then complained of not feeling well after a rew hours. He did eat lunch.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Exposure during pregnancy, Hypoaesthesia, Rhinorrhoea, Vomiting
Clinical narrative: Runny nose, coughing, numbness in arm (entire), some vomiting with coughing fits. No treatment.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Headache, Musculoskeletal discomfort, Nausea, Paraesthesia
Clinical narrative: Vertigo, Nausea, Clammy, Tingling in fingers, HA, neck tension.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Vertigo
Clinical narrative: Vertigo, Nausea, Clammy, Tingling in fingers, HA, neck tension.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Laboratory test normal, Pyrexia, Respiratory arrest
Clinical narrative: Seizure 30 minutes straight. Stopped breathing. Hospital 3 nights. Fever 104.
Sex: M
Vaccine: HEP
Symptoms: Cerebral haemorrhage, Convulsion, Eye haemorrhage, Hydrocephalus, Thrombosis
Clinical narrative: After having the vaccination, two months later my son began having blood clots in his eyes, hemorrhaging in his eyes and multiple seizures. He now has to take anti seizure meds daily and suffered from bleeding and fluid on his brain.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Dizzy and nauseous immediately after administration. Patient sat down, put fan on her and gave water. She felt better and recovered in about 10 minutes.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Full bosy urticaria.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Myalgia, Pain in extremity, X-ray, X-ray limb
Clinical narrative: Horrible Arm Pain, unable to move arm. Went to Urgent Care next morning (Aug 20, 2014).  Received prescription for muscle relaxant, pain (hydrocodone), to relieve symptoms. Advised to also take Naproxen 500. Could not move arm for 2 days. One week after vaccine before arm started feeling better.  It has been over 2 weeks now and I still have some muscle pain in arm.
Age: 1.29
Sex: M
Vaccine: MMR, PNC13
Symptoms: Crying, Diarrhoea, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Fever 104.  Crying and irritability.  2x2 inch induration at site of injection for 8 days.  Pain, heat, and bright erythema at site of injection x 8 days.  Diarrhea for 7 days.
Age: 1.29
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site warmth, Irritability, Pyrexia
Clinical narrative: Fever 104.  Crying and irritability.  2x2 inch induration at site of injection for 8 days.  Pain, heat, and bright erythema at site of injection x 8 days.  Diarrhea for 7 days.
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. The reporter stated that on 12-AUG-2014 the patient was inadvertently administered expired (Oka/Merck) VARIVAX (lot # 0186AE expiration date: 18-JAN-2014, dose, units, route of administration, anatomical location were not reported. No adverse effects reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Local swelling, Pain, Rash generalised
Clinical narrative: A rash all over and pain, swelling in feet, knees and hands began Saturday evening and slowly began to resolve. Pt did not seek or require medical treatment. Pain was moderate to severe.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Burning sensation, Dysphagia, Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: History of present illness from office of 8/22/14: Concerned for possible reaction to PPV23 vaccine (given on 8/20/14). The arm was sore immediately after injections; reports that the R upper anterior biceps region became swollen and red 2 hours later. No fever or chills. Felt short of breath, hard to swallow- feels like throat is clogged. No hives/rash. No difficulty swallowing, facial edema, wheezing or stridor. Went to ER last night (report not available). Does have Rx with her for NORCO 5-325 and Clindamycin (from ER). POC: Advised not to fill Clindamycin or NORCO prescriptions. This does not appear to be cellulitis but instead a localized reaction to the injection. SOLU MEDROL injection today. Cold compressess the area. May take acetaminophen as directed. BENADRYL as directed for itching. Advised if develop shortness of breath, stridor, face, eyes, or mouth/tongue swelling or hives to go to ER. Hospital ED 8/21/14 (just before midnight to early morning): This is a 30 yr old...She states by the time she got home she noticed some localized redness around the area and seemed to progress by getting larger and larger and tracking further down the arm. Because she is having quite a bit of a burning sensation and the redness there, she was concerned and came to in for evaluation. She denies any itching, fever, chills. 8/28/14 @ 2:25 I called patient and asked how her arm is doing. She said that after that shot (SOLU MEDROL) her arm was better by the time she go home. The swelling and redness went away. The soreness lingered till the next day.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pain in extremity, Throat tightness
Clinical narrative: History of present illness from office of 8/22/14: Concerned for possible reaction to PPV23 vaccine (given on 8/20/14). The arm was sore immediately after injections; reports that the R upper anterior biceps region became swollen and red 2 hours later. No fever or chills. Felt short of breath, hard to swallow- feels like throat is clogged. No hives/rash. No difficulty swallowing, facial edema, wheezing or stridor. Went to ER last night (report not available). Does have Rx with her for NORCO 5-325 and Clindamycin (from ER). POC: Advised not to fill Clindamycin or NORCO prescriptions. This does not appear to be cellulitis but instead a localized reaction to the injection. SOLU MEDROL injection today. Cold compressess the area. May take acetaminophen as directed. BENADRYL as directed for itching. Advised if develop shortness of breath, stridor, face, eyes, or mouth/tongue swelling or hives to go to ER. Hospital ED 8/21/14 (just before midnight to early morning): This is a 30 yr old...She states by the time she got home she noticed some localized redness around the area and seemed to progress by getting larger and larger and tracking further down the arm. Because she is having quite a bit of a burning sensation and the redness there, she was concerned and came to in for evaluation. She denies any itching, fever, chills. 8/28/14 @ 2:25 I called patient and asked how her arm is doing. She said that after that shot (SOLU MEDROL) her arm was better by the time she go home. The swelling and redness went away. The soreness lingered till the next day.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient had urticarial rash 1 week after GARDASIL vaccine 8/9/14; Rash 8/16/14. Mom had pictures on phone. Rash resolved at office visit 8-19-14. 15 year old female presents with c/ rash started 8/16 under arms trunk LE UE; very itchy; mom took pictures - c/w urticaria-hives on back and thighs; had GARDASIL vaccine 1 week prior to rash; no recent illness, no new foods, lotions or other known exposures; mom concerned b/c she read online other reports (from patients/families) of hives 1 week or more following GARDASIL vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Body temperature increased, Cellulitis, Injection site erythema
Clinical narrative: Initial information received on 27 August 2014 from a healthcare provider. It represents one of a group of three patients who experienced similar adverse events after vaccination with ADACEL; the other two patients are captured in case number 2014SA118214. A patient (age and gender not reported) was vaccinated intramuscularly in August 2014 (date not specified) with ADACEL lot # U4902BA. The dose and site of administration was not reported. On an unspecified date in August 2014, the patient experienced a low grade temperature, erythema at the injection site was seen and treated for cellulitis. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. It was reported that the patient recovered on an unreported date. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on back, trunk. Symptoms day 32-current.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded after 10 mins after administration of vaccine. Gave juice and crackers, he laid down for 10 more mins, took BP-within normal range, felt fine and left after 10 mins.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Dry mouth, Eye swelling, Lip swelling, Swelling face
Clinical narrative: Facial swelling, eyes swollen, mouth dry, coughing lips swollen, rash on abd - ambulance called -> ER - Reaction happened within 1 hour of administration - BENADRYL, Epipen - Rx for steroids.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Nodule, Rash, Skin warm, Swelling
Clinical narrative: Patient called 2 days later describing a local reaction with a knot on her arm. Rash the length of a finger and felt very hot to the touch. She put on ice and took some TYLENOL as comfort.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Blood test, Contusion, Crying, Dyspnoea
Clinical narrative: 8-7-14- C/O Fatigue- weak feeling. 8-8-14 C/O more fatigue Sx-severe muscle weakness-Fever- uncontrolled crying, contusion- SOB- Went to ER-was in ER 4 hours-Had blood work- IV to bring fever down.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fatigue, Muscular weakness, Pyrexia
Clinical narrative: 8-7-14- C/O Fatigue- weak feeling. 8-8-14 C/O more fatigue Sx-severe muscle weakness-Fever- uncontrolled crying, contusion- SOB- Went to ER-was in ER 4 hours-Had blood work- IV to bring fever down.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cyanosis, Screaming, Staring, Tremor, Vaccination complication
Clinical narrative: 8/29/14 Mother reports that infant had adverse reaction to second DTaP on 4-09-14. Screaming all afternoon and throughout the night. Also noted tremors, staring episode, hands turned blue while giving bath; tired? Seizure?? No further activity since.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: 8/29/14 mother reports today 8-29-14 that infant had screaming all afternoon and throughout the night after receiving first DTaP 1-29-14.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Heart rate irregular, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, soreness of upper Rt arm (elbow) to shoulder, warm to the touch, irregular heart beat and went to ER w/diagnosis of PAC's, gave steroid pack and better after taking.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Supraventricular extrasystoles
Clinical narrative: Redness, swelling, soreness of upper Rt arm (elbow) to shoulder, warm to the touch, irregular heart beat and went to ER w/diagnosis of PAC's, gave steroid pack and better after taking.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site nodule
Clinical narrative: Patient had almond size knot in left leg where he received the DTaP and Hep B vaccines.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling/pain/pruritus at injection site, associated rise in BP to 166/100; advised by her Dr. to take BENADRYL and apply ice to site.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: Hives on (R) arm. No other reactions. No treatment. Hives appeared approx. 24 hours after IM injection warm discrete, 2cm in diameter, raised, red, minimal pruritus.
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Blood test, Bone scan, Joint swelling, Osteoarthritis
Clinical narrative: A few days after I received my 7th Anthrax shot. I had swelling and pain in my knees and hip joints. After returning from deployment I seen a orthopedic and had a bone density scan and x-rays. He diagnosed me with osteoarthritis. Symptoms have decreased over this time.
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: X-ray
Clinical narrative: A few days after I received my 7th Anthrax shot. I had swelling and pain in my knees and hip joints. After returning from deployment I seen a orthopedic and had a bone density scan and x-rays. He diagnosed me with osteoarthritis. Symptoms have decreased over this time.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Local swelling, Pain in extremity, Skin tightness, Tenderness
Clinical narrative: Arm swelling elbow to shoulder 1-2d after tender, tightness worsening pain. Treatment: BENADRYL, AUGMENTIN.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Pt has been having arm pain for 2 months since she got Hep B shot on 7/2/14.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Skin reaction to KINRIX (IPC and DTAP) (L) deltoid area.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Laboratory test
Clinical narrative: Vaccines were given 8/28/14 at 10:17AM. Mom reported 3 min seizure occurring at about 12:10 PM. Mom took pt to ER.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site warmth, Local swelling
Clinical narrative: Localized swelling, redness and itching night of injection date. Became worse the next day and fluid filled blisters began forming also had fever and muscle aches on 8/13/14. On 8/14/14 14 x 7 cm area of induration and redness around injection site with 2 1/2 - 3 1/2 cm area of fluid filled blisters about 40-50. Site is warm to touch.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Myalgia, Pruritus, Pyrexia
Clinical narrative: Localized swelling, redness and itching night of injection date. Became worse the next day and fluid filled blisters began forming also had fever and muscle aches on 8/13/14. On 8/14/14 14 x 7 cm area of induration and redness around injection site with 2 1/2 - 3 1/2 cm area of fluid filled blisters about 40-50. Site is warm to touch.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Pallor
Clinical narrative: On 8-18-14 at approximty 11:15 AM patient had Rc'd HPV and began a jerking movement of arm, color was pale. He told me he "gets low blood sugar and had not ate." Mother had soda in purse. I called in admin we placed patient supine in floor, cool compress to back of neck and head, legs placed in chair. Holding his head he drank soda BP was 120/70 manual by RN. 10 min assisted Pt to chair after finishs soda. Patient started feeling well. Mother request to proceed with with MENVEO. After given patient walked to car.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Crying, Dyskinesia, Nausea, Pallor
Clinical narrative: Brother had jerking movement with inj. Patient had his approx 10 min before. After seeing brother he felt nausea, crying, white in color. He sit in chair BP 102/60 after cool compress and seeing brother was OK. Patient walked to car.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 08/07/14 1620 TC from father c/o arm muscle that vaccinations in swelled and hot to touch. Parent denied all other s/s. RN/Adm 08-08-14/15 30 TC to parent to check on pt and PCP appt. Father states "Dr was uncertain type of reaction so gave him antibiotic OTC BENADRYL and methylprednisolone." RN 8-11-14/0900 TC to father states "swelling is down, no more pain and patient c/o itchiness. PCP evaluation Wed. It is better." 's
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Muscle spasms, Pain in extremity
Clinical narrative: Joint pain - bilateral knees since 2013. Left hand pain/cramping since 2013 back pain.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Erythema, Local swelling
Clinical narrative: Mother reported on 8/22/2014 that the patient had redness and swelling to the arm.  Mother reported that the patient was having trouble breathing on 8/21/2014. Mother was instructed to take the patient to the ER.  Mother did take the patient on 8/22/2014.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV, TDAP, PPV
Symptoms: Axillary pain, Chest pain, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: REDNESS, SWELLING, PAIN, SLIGHT BRUISING AT INJECTION SITE. PAIN UNDERNEATH ARMPIT, SOME CHEST PAINS UPON INHALATIONS.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV, TDAP, PPV
Symptoms: Injection site swelling, Painful respiration
Clinical narrative: REDNESS, SWELLING, PAIN, SLIGHT BRUISING AT INJECTION SITE. PAIN UNDERNEATH ARMPIT, SOME CHEST PAINS UPON INHALATIONS.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV, TDAP, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: REDNESS, SWELLING, PAIN, SLIGHT BRUISING AT INJECTION SITE. PAIN UNDERNEATH ARMPIT, SOME CHEST PAINS UPON INHALATIONS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Mother called the morning after shots to report the child's face was swollen "just like it was when he was allergic to erythromycin".  Mother gave liquid Benadryl and was told to take to ER.  Mother took child to PMD instead and he told her to keep giving Benadryl.
Age: 1.38
Sex: F
Vaccine: HIBV, PPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: High fever (over 104 degrees) that was difficult to "get down".  Patient appreared lethargic.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold
Clinical narrative: Began shivering and feeling very cold despite room temp of 84.  Wife took temperature and it was 101.  This lasted for nearly 24 hours....took Tylenol 825 mg that evening and again the next morning.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: I had developed a large egg size swelling on my arm left arm at the injection site.  It was hot, inflamed, extremely painful. There was also a quarter size cluster of blisters on my right foot.  They itched and hurt.  I called the advice nurse and was told that I could not have a reaction to the shot that quickly.  After several more days where the swelling and pain got worse on  the arm and foot I insisted on seeing a doctor.  On 08/28/2014 I was seen by a doctor who told me I had developed shingles from the shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: I had developed a large egg size swelling on my arm left arm at the injection site.  It was hot, inflamed, extremely painful. There was also a quarter size cluster of blisters on my right foot.  They itched and hurt.  I called the advice nurse and was told that I could not have a reaction to the shot that quickly.  After several more days where the swelling and pain got worse on  the arm and foot I insisted on seeing a doctor.  On 08/28/2014 I was seen by a doctor who told me I had developed shingles from the shot.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient reported feeling fine until taking a shower about 4pm then felt dizzy.  Went to doctor & was prescribed meclizine for dizziness.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Vaccination complication
Clinical narrative: PATIENT WAS ADMINISTERED A FLUSHOT AND HAD AN ADVERSE REACTION, POSSIBLY ANAPHYLAXIS. PATIENT CLAIMED TO HAVE SHORTNESS OF BREATH AND TIGHTNESS OF CHEST WALL.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Repeat #3 dose given early in error will still need #3 dose on schedule.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection area is warm to touch, red and swollen. Patient is contacting her physician.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphemia
Clinical narrative: Patient started stuttering after received shot. This last approximately 10-12 days.
Age: 7.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Atrioventricular block first degree, Chest pain, Pain in extremity, Palpitations
Clinical narrative: Per client's mother - 8/28 - Bilateral arm pain. 9/1/14 - Palpitations and chest pain.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 28-AUG-2014 the patient was vaccinated with 0.5ml dose of PNEUMOVAX23 lot # J010396, Exp. date 16-FEB-2015, frequency was reported as once, intramuscular. On 28-AUG-2014 the patient experienced redness, pain and swelling at injection site. The patient did not seek medical attention. The reporter stated that no treatment was given, just watching at this point. The outcome of redness, pain and swelling at injection site was unknown. The reporter stated that there were 3 injections administered from vial and the reaction happened in 2 of the 3 injections (another one was captured in 1409USA000047). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 27-AUG-2014 the patient was vaccinated with 0.5 ml dose of PNEUMOVAX23 lot # J010396, Exp date: 16-FEB-2015, frequency was reported as once, intramuscular. On an unspecified date in August 2014 the patient experienced  redness, pain and swelling at injection site. The patient did not seek medical attention. The reporter stated that no treatment was given, just watching at this ponit. The outcome of redness, pain and swelling at injection site was unknown. The reporter stated that there were 3  injections administered from vial and the reaction happened in 2 of the 3 injections (another one was captured in 1409USA000523). Additonal information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. ON 25-AUG-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J005849, expiration date 17-AUG-2014)(dose, route, unspecified). No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 20-AUG-2014, 2 patients were vaccinated with a dose of LIQUIPD PEDVAXHIB (lot number, expiration date, dose and route were not reported) that was improperly stored at 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 20-AUG-2014, 2 patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route were not reported) that was improperly stored at 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. ON 05-AUG-2014 the patient was vaccinated with a d ose of ZOSTAVAX (dose, route, lot # and expiration date were not reported). Approximately in August 2014 the patient experienced injection site reaction: redness and swelling at the injection site of the ZOSTAVAX and unspecified period of   time after receiving ZOSTAVAX. The reporter believed that the injection site redness and swelling developed "within 2 days" of receiving ZOSTAVAX. The reporter was not aware of any treatment that was provided and he stated that there ws a nurse practitioner in her patient's family. ON Saturday 09-AUG_2014, the patient contacted the pharmacist and informed him that the injection sites of her were "okay" so the reporter believed that the injection site redness and swelling of the patient ws resolved and th patient recovered. The patient did not seek any medical attention. The relatedness between the event of "redness and swelling at the injection site" and ZOSTAVAX was not reported. This is the one of two reports received from the same reporter (MARRS#1408USA007708 the patient's husband case). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). Approximately in August 2014 the patient experienced injection site reaction: redness and swelling at the injection site of the ZOSTAVAX and unspecified period of time after receiving ZOSTAVAX. The reporter believed that the injection site redness and swelling developed  "within 2 days" of receiving ZOSTAVAX. The reporter was not aware of any treatment that ws provided and he stated that there was a nurse practitioner in the patient's family. On Saturday 09-AUG-2014, the patient's wife contacted the pharmacist and informed him that the injection sites of her husband were "okay", so the reporter believed that the injection site redness and swelling of the patient were resolved and the patient recovered. The patient did not seek any medical attention. The relatedness between the event of "redness and swelling at the injection site" and ZOSTAVAX was not reported. This is the one of two reports received from the same reporter (MARRS#1409USA001292 the patients wife's case). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date the patients experienced low or negative titer for hepatitis B after completing the vaccination series with hepatitis b vaccine (manufacturer unknown) (strength, route not reported) on an unknown date. The outcome of low or negative titer is unknown. This case is linked to the case 1408USA011777 via same reporter link. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 year old male patient. The patient's medical history and past drug history were unknown. On 16-AUG-2014 the patient was accidentally vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration not reported, lot# reported as J006246) that expired on 03-AUG-2014. Concomitant therapies included LEVEMIR, metformin, AMARYL, LIPITOR and JANUVIA. Pharmacist reported that no phone call was received from the patient reporting any adverse events. This is one of several reports from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Injection site erythema, Injection site induration, Injection site mass, Injection site reaction
Clinical narrative: This spontaneous report as received from a 55 year old female patient who was also a registered nurse refers to herself. The patient had no allergies. On 04-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On 05-AUG-2014 the patient experienced the injection site reaction. The injection site was red, approximately 8 cm wide, with a hard lump. The patient visited physician, but no treatment was given. Moreover approximately on 12-AUG-2014 (reported as a week after the ZOSTAVAX was administrated) the patient experienced hair loss. The patient recovered from the injection site was red, approximately 8 cm wide, with a hard lump. The outcome of hair loss was reported as not recovered. The relatedness between all events and ZOSTAVAX was not specified. Additional information is not expected as there was no consent for contact.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an 81 year old female patient refers to herself. The patient's medical history included shingles 10 years ago (in August 2004). The patient's drug reactions/allergies included penicillin (dosage/frequency/manufacture unknown). On an unspecified date earlier in 2014 the patient was vaccinated with a dose of ZOSTAVAX, one single shot, subcutaneous, (lot#, dose# unspecified) for the prevention of shingles. No concomitant medication was taken. In May 2014 the patient was diagnosed with shingles. No lab diagnostics studies were performed. The patient sought medical attention. The outcome of shingles was reported as recovered in 2014. 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 medical assistant refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was vaccinated with expired dose of MMR II batch #J008882, lot# 0293AA with expiration date: 27-JUL-2014; route of administration dose and indication were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a 2 month old patient. The nurse reported that the patient received PEDIARIX (manufacturer unknown) and PREVNAR 13 (manufacturer unknown), ROTATEQ and RECOMBIVAX HB (dose, route not reported) on 27-AUG-2014. The nurse mentioned the patient was supposed to receive (OMPC) (PEDVAX HIB), but received RECOMBIVAX HB in error. No adverse symptoms were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with an allergy to CELEBREX, iodine and ibuprofen. No pertinent medical history was reported. On 12-AUG-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU, Lot # J014812 to prevent shingles (dose and route of administration not reported). Concomitant therapies included atorvastatin, ABILIFY, SPIRIVA, oxycodone, fluticasone, fluticasone propionate, ADVAIR, gabapentin, famotidine (manufacturer unknown), DETROL LA, KLOR-CON, ropinirole, fluticasone, furosemide and tizanidine. In August 2014 the patient experienced injection site reaction after vaccination with ZOSTAVAX. The patient described injection site as itchy and red. The patient sought medical attention by contacting the pharmacist. No lab diagnostics studies were performed. No treatment was given to the patient to treat the events. The outcome of injection site reaction described as itchy and red was reported as not recovered. Relatedness between ZOSTAVAX and injection site reaction described as itchy and red was not provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 18 year old male patient. On 19-AUG-2014 the patient experienced inadvertent administration of ZOSTAVAX, dose: 0.65 ml (millilitres), subcutaneous. On 19-AUG-2014, it was reported that the patient was due for his first dose of VARIVAX (Merck). It was reported that an inadvertent administration of ZOSTAVAX an 18 year old patient. No adverse experience reported. The outcome of inadvertent administration of ZOSTAVAX to an 18 year old patient is unknown. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 20-AUG-2014, 2 patients were vaccinated with a dose of M-M-R II (lot number, expiration date, dose and route were not reported) that was improperly stored at 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that the patient completed Hepatitis B vaccine (manufacturer unknown) series in 1992-1993, had titer drawn and result came out low and patient was recommended to repeat the series. The reporter reported that for repeat series, RECOMBIVAX HB was used and patient received first dose of new series on 31-JUL-2014. The reporter also stated that second dose of RECOMBIVAX HB (for the new series) was not due about a month later but nurse administered a second dose of RECOMBIVAX HB on 19-AUG-2014, about 10 days too early than recommended. No adverse effects reported. The outcome of events reported is unknown. The patient sought medical attention. No product quality complaint was involved. This case is linked to the case 1409USA001257 via same reporter link. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Dyspnoea, Myalgia, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a Other Company refers to a 65 year old male patient. On 18-SEP-2013 the patient was vaccinated with PNEUMOVAX 23 first dose in the left arm, lot # J007059, unknown route of administration. Other suspect therapies included AFLURIA first dose in right arm, lot# R52607, unknown route of administration. On 18-SEP-2013, the patient experienced myalgia, chills urticaria, pruritus and shortness of breath. The outcome of shortness of breath, chills, urticaria, myalgia and pruritus was reported as recovered on unspecified date in 2013. Relatedness between events and vaccination with PNEUMOVAX 23 and AFLURIA was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Blood test, Chest X-ray, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Pain couldn't hardly walk headache very irritable very tired muscle spasms trouble breathing
Age: 16.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Headache, Irritability, Muscle spasms, Pain, Urine analysis
Clinical narrative: Pain couldn't hardly walk headache very irritable very tired muscle spasms trouble breathing
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Dyspnoea, Vomiting
Clinical narrative: He experienced weakness and dizziness first. About 20 minutes later, trouble breathing, ran outside to get fresh air. 15 minutes later, he vomited 1x.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. There were no pertinent medical history or drug reactions/allergies. On 28-AUG-2014, the patient was vaccinated with ZOSTAVAX (lot # K000996, expiration date: 13-MAR-2015), 0.65 ml, subcutaneous in deltoid region of the upper arm. Concomitant therapy included Temazepam. On 29-AUG-2014, patient developed swelling and a "hot lump" at the injection site. The patient sought medical attention by visiting pharmacy and was advised by the pharmacist to ice the affected area. No lab diagnostics studies were performed. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Pallor, Vomiting
Clinical narrative: A few minutes (3-5 min) after vaccine administration (just Hep A was given) she stood to do eye testing, became pale began to pass out and vomited. Had not eaten/drank that morning. No LOC. Recovered quickly with laying down.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to unspecified number of unknown age and gender. The reporter stated that since 06-JUL-2014 those patients were administered VARIVAX (dose, units, route of administration, anatomical location, lot number were not reported) which was not stored properly. No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: swelling of upper arm in area below inoculation site, down to elbow, area is hot and blotchy red in color