chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Splenic rupture, Syncope, Tibia fracture, Traumatic liver injury
Clinical narrative: After leaving the clinic patient was invloved in motor vechicle accident where he was air-lifted to hospital.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Alopecia, Alopecia areata, Thyroid function test
Clinical narrative: Hair loss in one spot.  Completely bare as if it had been freshly shaved, only with no stubble or growth at all.  The spot got larger after a couple of weeks and we sought medical treatment.  She developed several other similar spots over the course of a year.
Age: 14.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was to receive 2nd dose of Varivax but mistakenly received Zostavax. CDC was contacted and informed us that Zostavax was ok for the second dose of Varivax and no further immunization would be necessary. Patient was made aware of the mix-up and was instructed to call the pharmacy if she experienced any adverse reaction as soon as possible. Pharmacy will continue following up with patient.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Local swelling, Skin warm
Clinical narrative: Had swelling/warmth around injection site and extending down arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Client became "dizzy" approx. 5 min after vaccination. Vitals taken - WNL. Client drank H2O without difficulty; recovered completely approx 1:40 PM.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Case number PHEH2013US016133, is an initial spontaneous report received from a medical assistant on 29 Jul 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A12128), intramuscularly on 29 Jul 2013. On the same day after vaccination, he fainted. He was awakened with ammonia, given popsicle and Hershey bar. His vitals were rechecked, blood pressure and heart rate were okay. Physician checked eyes and ears of the patient and he was kept in office for an additional 20 minutes before he was discharged from the office. The outcome was reported as unknown. The seriousness and causality of the event were not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Case number PHEH2013US016374 is an initial spontaneous report received from a nurse on 18 Jul 2013. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12011, expiry date: Feb 2014) on 12 Jul 2013. On 14 Jul 2013, his parent called to report that he experienced redness, swelling and hardness at vaccination site and he had a body temperature of 100 F degree. He went to see an urgent care practitioner and was diagnosed with cellulitis at the injection site. The exact date of onset of reaction was not known. He was prescribed BACTRIM and the office stated that they were not quite sure whether that was right. The outcome of the event was not reported. No further information was provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt received ZOSTAVAX on 7-10-13, went to see PCP on 8-5-13 and diagnosed with a rash thought to be shingles. Pt unsure of exact onset.. few days prior to 8-5-13 visit with PCP. Treated with VALTREX 1gm Q12 hours x 10d and Pred 40mg QD x 5d.
Age: 32.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Abdominal pain, Anaemia, Full blood count, Hypotension, Metabolic function test
Clinical narrative: Nausea, vomiting, abdominal pain, hypotension, anemia.
Age: 32.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting, abdominal pain, hypotension, anemia.
Age: 1.74
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Hives like rash on face, chest, w/ in 30 minutes of vaccinations given.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Convulsion, Dyspnoea, Laboratory test normal, Loss of consciousness
Clinical narrative: Father reports via telephone call, approx 5-10 min after vaccinations, pt complained of "shortness of breath, passed out, then had seizure for 40 seconds." Pt taken to ER where "vital signs were normal." Dad reports no prior history of seizures.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Convulsion, Dyspnoea, Loss of consciousness
Clinical narrative: Father reports via telephone call, approx 5-10 min after vaccinations, pt complained of "shortness of breath, passed out, then had seizure for 40 seconds." Pt taken to ER where "vital signs were normal." Dad reports no prior history of seizures.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 7/26/12-Left arm redness, tenderness and warm to touch. Red streak noted around border 3-4 days ago.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Skin warm, Swelling
Clinical narrative: Child has redness on both sites, received Tdap #5 and MCV4 on 7/31/13. Warm to touch. Childs appetite good, no breathing distress. Follow up: patient came back after 2 days swelling gone down pt doing very well.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Body temperature increased, Chills, Cough, Dizziness
Clinical narrative: 7/29/13 about 7 pm feeling "achy" and c/o's stiff neck. Chills and nausea -temp 101 degrees. Vomiting at 2 am; Next day 7/20 tem 100 degrees. Left work early; 7-31-13-> developed cough and some dizziness -> better later that same prn (7/31/13) advised to go to ER or her provider-had appt scheduled with her provider but canceled apt.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Vomiting
Clinical narrative: 7/29/13 about 7 pm feeling "achy" and c/o's stiff neck. Chills and nausea -temp 101 degrees. Vomiting at 2 am; Next day 7/20 tem 100 degrees. Left work early; 7-31-13-> developed cough and some dizziness -> better later that same prn (7/31/13) advised to go to ER or her provider-had appt scheduled with her provider but canceled apt.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Cheilitis, Oral pain, Swollen tongue
Clinical narrative: Sore mouth and red lips after 1st dose. Swollen tongue after 2nd pill. Patient was treated with Lidocaine solution.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: 2 hours after receiving (PEDIARIX, HIB, PCV13, HEP A) Pt broke out with hives and itchiness all over body. Mother call oncologist and he informed her to give pt BENADRYL.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Catheterisation cardiac normal, Chest pain, Dyspnoea, Electrocardiogram abnormal, Hyperhidrosis
Clinical narrative: Woke up with sharp chest pain, radiating down left side/arm. Assoc with SOB, diaphoresis. Seen at ER had pos troponin, EKG changes. Admitted had neg heart cath.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: Woke up with sharp chest pain, radiating down left side/arm. Assoc with SOB, diaphoresis. Seen at ER had pos troponin, EKG changes. Admitted had neg heart cath.
Age: 40.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: Woke up with sharp chest pain, radiating down left side/arm. Assoc with SOB, diaphoresis. Seen at ER had pos troponin, EKG changes. Admitted had neg heart cath.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Erythema, Induration, Skin warm, Swelling
Clinical narrative: 5x6 cm area redness and swelling, mildly warm. No tenderness, indurated, no fluctuance. C/O some chills. No fever.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Hypotension, Pallor, Syncope, Tachycardia
Clinical narrative: Fainted, jerking. Hypotensive, pale, tachycardic.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Poor quality drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to 9 unspecified patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date the patients were vaccinated with RECOMBIVAX HB lot # J001183. Dose, route and frequency were not provided. On an unknown date the patients received doses of RECOMBIVAX HB from recalled lot number. No adverse event was reported. The reporter considered patients received doses of RECOMBIVAX HB from recalled lot number to be not related to RECOMBIVAX HB. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 year old male patient. On an unknown date the patient was vaccinated with PROQUAD (lot # and expiry date unspecified) injection (dose, route and anatomical location unspecified). Other suspect therapies included MMR II. It was also reported that the patient received a dose of VARIVAX (lot # and expiry date unspecified) (dose, route and anatomical location unspecified) administered on an unknown date. The nurse reported that patient had only received a single dose of both VARIVAX and PROQUAD on an unspecified date. Additional information has been requested. This is a corrected report. Therapy of VARIVAX was removed from therapy tab and was replaced for MMR II. The event of inappropriate schedule was added. Narrative was updated.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor, Presyncope, Visual impairment
Clinical narrative: This spontaneous rep rot as received from the director of a health department refers to 12 year old female patient. Information on medical history was not reported. It was reported that in July 2013 reported as last week, the patient was vaccinated with GARADASIL (lot#, expiry date not provided)(dose, strength, route, frequency, indication not reported) and two other unspecified vaccines. Immediately after administration the patient started to see spots and her skin color became pale. It was also reported that the patient did not fully faint. The outcome of the events was unknown. The reporter did not assess relationship between the therapy with GARDASIL and the adverse events. This is one of several reports from the same source. 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 pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 31-JUL-2013 the patient was vaccinated with M-M-R II  lot # 1119AA (expiration date 12-JUL-2013) (albumin status: HSA). No concomitant medications were reported. It was reported that a dose of expired M-M-R II was administered "today" (21-JUIL-2013). No adverse effects were reported. No further details were provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from the director of a health department refers to an unspecified number of patients of unknown age and gender. Information on medical history was not reported. It was reported that on unspecified date every patient that received GARDASIL (lot#, expiry date not provided)(dose, strength, route, frequency, indication not reported) stated "wow that really hurts" (dates were unspecified by the reporter). The outcome of the event was unknown. The reporter did not assess relationship between the therapy with GARDASIL and the adverse event. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-JAN-2008, the patient was vaccinated with first dose of VAQTA (lot #, expiry not reported), 0.5 ml, intramuscularly. On 07-JUL-2008, the patient was vaccinated with dose 2 of VAQTA (lot #, expiry not reported), 0.5 ml intramuscularly. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 unspecified patients of unknown age and gender. On an unknown date the patient were vaccinated with a doses of RECOMBIVAX HB (units not provided) 0.5 ml intramuscularly) (lot # H020604 exp. date 10-FEB-2015), and lot # H018691, exp. 07-FEB-2015). RECOMBIVAX HB were not supported by in house temperature stability data". No adverse effects were reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient. On 03-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml subcutaneous injection, in the left deltoid region), (lot number and expiration date were not reported). In approximately July 2013, with "a couple" days, the patient had itching to injection site, bu there was no pain. On 11-JUL-2013 (reported as "today") the patient noticed "redness that was approximately the size of 2 quarters surrounding the injection site" and itching continued, but there was no pain. The patient sought medical attention via contacting pharmacist. There was no treatment given for adverse events. At the time of the report adverse events persisted. The relatedness between therapy with ZOSTAVAX and itching and adverse events was not reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative, Varicella virus test
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient was vaccinated with a first dose of M-M-R II on 24-MAY-1991. Lot number, dosing information and route of administration were not provided. A second dose of M-M-R II was vaccinated on 02-AUG-2002. Lot number, dosing information and route of administration were not provided. A rubella titer was performed on an unspecified date after the second dose of M-M-R II and the patient was found to have a negative titer. A third dose of M-M-R II was administered on 26-JUN-2013. Therapy type, lot number, dosing information and route of administration were not provided. Another rubella titer was performed on 02-JUL-2013. The result of the titer were negative. Patient sought medical attention and went to the physician's office. The event outcome was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 24 year old female consumer refers to herself. In 2011 the patient was vaccinated her first and second dose of GARDASIL intramuscular. The patient was scheduled to receive the third dose in February 2012. The patient became pregnant in January 2012. The LMP and EDD were not known. After became pregnant, the third dose of GARDASIL had never been received. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse reported that the patient received the 1st dose of GARDASIL (dose, route and lot # not reported) on 09-JUL-2010 and the 2nd dose of GARDASIL (dose, route and lot # not reported) on 30-JUL-2013. No adverse effect was reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients. The medical assistant reported that numerous unspecified patients received GARDASIL (dose, route and lot # not reported) that went through an unsupported temperature excursion. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients. The medical assistant reported that numerous unspecified patients received doses of PNEUMOVAX23 (dose, route and lot # not reported) that went through an unsupported temperature excursion. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients. The medical assistant reported that numerous unspecified patients received doses of PEDVAXHIB (dose, route and lot # not reported) that went through an unsupported temperature excursion. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nursing assistant refers to herself. The patient had shingles in the past. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not reported) when she was below 50 years of age. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Headache, Injection site swelling, Oropharyngeal pain, Pyrexia
Clinical narrative: FEVER, VOMITING, ABDOMINAL PAIN, HEADACHE, SORE THROAT, MILD SWELLING AT INJECTION SITE.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: FEVER, VOMITING, ABDOMINAL PAIN, HEADACHE, SORE THROAT, MILD SWELLING AT INJECTION SITE.
Age: 0.1
Sex: F
Vaccine: HEPA, HIBV, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE
Age: 1.03
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Pruritus, Pyrexia, Rash
Clinical narrative: Acute onset of raised rash with central clearing and itching and fever; consistent with erythema multiforme.  Treated with oral antihistamines and fever reducer.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Diplopia, Headache, Nausea, Vomiting
Clinical narrative: Severe, debilitating headaches 2-3 times a week including nausea, vomiting and double vision. Headaches were at this frequency and intensity until early June.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Constipation, Diarrhoea, Dry eye, Dyspepsia
Clinical narrative: Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Endoscopy, Fatigue, Gastrooesophageal reflux disease, Headache, Migraine
Clinical narrative: Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Stool analysis
Clinical narrative: Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Dry eye, Endoscopy, Fatigue, Insomnia
Clinical narrative: Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine, Muscular weakness, Nausea, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Stool analysis, Vertigo
Clinical narrative: Head pressure, migraine, tingling in hands/arms, extreme fatigue, severe nausea, heart burn/acid reflux, diarrhea or constipation, weak muscles/body, dry eyes.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Severe pain and swelling in injection site, lack of mobility in arm that was injected, headache above both eyes, more pronounced above left eye for 4-5 days especially when looking up. General lethargy.
Age: 19.0
Sex: M
Vaccine: HEPA, HPVX, MEN, HEPA, HPV4, MNQ
Symptoms: Dizziness, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Fainted, convulsion type movements. About a 1 minute duration. Applied cold compresses, provided Sprite to patient, allowed to lie down until dizziness, pallor subsided.
Age: 19.0
Sex: M
Vaccine: HEPA, HPVX, MEN, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Fainted, convulsion type movements. About a 1 minute duration. Applied cold compresses, provided Sprite to patient, allowed to lie down until dizziness, pallor subsided.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient in his 70's. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date, a few days later after vaccination, the patient developed a severe case of shingles and was hospitalized on an unknown date. At the time of the report the patient's outcome was unknown. This case is serious due to hospitalization. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site mass, Oedema peripheral
Clinical narrative: ARM SWOLLEN, RED AND SITE WAS SLIGHTLY LUMPY.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site oedema, Pyrexia
Clinical narrative: Edema for six days after injection that covered the upper arm all the way around and down to elbow. Felt feverish the first night with chills. Symptoms went away after 6 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: MOTHER STATED THAT THE SAME DAY HER DAUGHTER RECEIVED VACCINATIONS HER RIGHT ARM BECAME SWOLLEN, RED, PAINFUL FROM ELBOW TO TOP OF SHOULDER SHE WAS THEN TAKEN TO EMERGENCY ROOM WHERE SHE RECEIVED CARE UNDER A PHYSICIAN WAS GIVEN STEROIDS AND WAS TOLD THAT SHE HAD A REACTION TO THE VACCINE SHE RECEIVED DOCUMENTED VACCINES THAT WERE GIVEN TO THE RIGHT ARM WERE KINRIX AND VARICELLA.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Lymphadenopathy, Pain in extremity
Clinical narrative: Patient with pain in arm, also having significant axillary lymph-node edema. Patient required re-eval in emergency room. Patient given course of antibiotics to r/o cellulitis.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary mass, Injection site pain
Clinical narrative: Patient with pain in arm, also having significant axillary lymph-node edema. Patient required re-eval in emergency room. Patient given course of antibiotics to r/o cellulitis.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Eye movement disorder, Tunnel vision
Clinical narrative: Very dizzy lightheaded tunnel vision eyes shifting back-and-forth from right to left very fast.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, pain, redness, warm to the touch.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Full blood count, Headache
Clinical narrative: Tdap given 8/5/13. Awakened w/ rigors, fatigue, occipital H/A. No fever.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Arthralgia, Arthritis, Burning sensation, Fatigue
Clinical narrative: Regular shot pain, never went away, needle was put in lower arm, then pulled out, put in again bone was nicked, had 2 MRIs, 1 xray, nerve test, steroids, came back with inflammation. Arthritis in shoulder, neck, foot, injection site is swollen. Received vaccine on October 15 2012 around a week later I was asking how long does it take for the pain of a flu shot to go away because my shot pain was still with me. (October 22 2012). I waited until March 1 2013 to see my family physician only because I had to go see him for my yearly physical. At this time my arm pain was getting worst. It was throbbing all the time and if I moved my arm it would feel like it was getting tired as if I over used it. Sometimes it felt numbness; dull aching pain getting some tingling and I have difficulty with doing simple exercise. Also my left foot was hurting with a persistent pain with aching all the time. Had an x ray. It looked like my bone was nicked as if the person who gave me the shot hit the bone pulled the needle out some and then inserted it in again to finish off the shot. My foot my diagnosis as Morton's neuroma. After seen other doctors. Both said I had arthritis in my shoulder and back of my neck also inflammation in the shoulder. Treatment has a steroid shot in my shoulder. Only helped somewhat. Also arthritis in my foot. As of today August 5, 2013 I am in constant pain in my arm. Also by the site of the injection. I have a constant muscle and joint pain in my arm with sometimes muscle tightness and weakness as an on and off feeling. Once in a while my hand will have a tremor in it if I am holding something. My feet and fingers have a tingling feeling along with a burning sensation in my feet as if I have been standing on them all day. I seem to get to feel a fatigue feeling of wanting to go to sleep at any given time of the day. But yet I have a hard time sleeping (where at one time I was able to fall asleep right away). If my arm is overworked it gets a tired feeling fast and I have to switch to using the other arm. To finish my work. This is ongoing. If I also use the arm too much it getting a swollen effect in the area where the shot was given. In all I cannot sleep on my left arm for more than a 3 minute span. The arm is in constant throbbing pain where sometimes it will start twitching and get tight then gets weak. If someone bumps my arm the pain seems to throb more. So I have burning in my (feet), tingling, tightness, weakness. Fatigue. Swelling, hand tremors, inflammation, arthritis, some anxiety with stress about what is happening to my body because of this shot. It appears that sometimes is going on and my body is not getting any better since the shot.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Inflammation, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Regular shot pain, never went away, needle was put in lower arm, then pulled out, put in again bone was nicked, had 2 MRIs, 1 xray, nerve test, steroids, came back with inflammation. Arthritis in shoulder, neck, foot, injection site is swollen. Received vaccine on October 15 2012 around a week later I was asking how long does it take for the pain of a flu shot to go away because my shot pain was still with me. (October 22 2012). I waited until March 1 2013 to see my family physician only because I had to go see him for my yearly physical. At this time my arm pain was getting worst. It was throbbing all the time and if I moved my arm it would feel like it was getting tired as if I over used it. Sometimes it felt numbness; dull aching pain getting some tingling and I have difficulty with doing simple exercise. Also my left foot was hurting with a persistent pain with aching all the time. Had an x ray. It looked like my bone was nicked as if the person who gave me the shot hit the bone pulled the needle out some and then inserted it in again to finish off the shot. My foot my diagnosis as Morton's neuroma. After seen other doctors. Both said I had arthritis in my shoulder and back of my neck also inflammation in the shoulder. Treatment has a steroid shot in my shoulder. Only helped somewhat. Also arthritis in my foot. As of today August 5, 2013 I am in constant pain in my arm. Also by the site of the injection. I have a constant muscle and joint pain in my arm with sometimes muscle tightness and weakness as an on and off feeling. Once in a while my hand will have a tremor in it if I am holding something. My feet and fingers have a tingling feeling along with a burning sensation in my feet as if I have been standing on them all day. I seem to get to feel a fatigue feeling of wanting to go to sleep at any given time of the day. But yet I have a hard time sleeping (where at one time I was able to fall asleep right away). If my arm is overworked it gets a tired feeling fast and I have to switch to using the other arm. To finish my work. This is ongoing. If I also use the arm too much it getting a swollen effect in the area where the shot was given. In all I cannot sleep on my left arm for more than a 3 minute span. The arm is in constant throbbing pain where sometimes it will start twitching and get tight then gets weak. If someone bumps my arm the pain seems to throb more. So I have burning in my (feet), tingling, tightness, weakness. Fatigue. Swelling, hand tremors, inflammation, arthritis, some anxiety with stress about what is happening to my body because of this shot. It appears that sometimes is going on and my body is not getting any better since the shot.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Morton's neuroma, Muscle tightness, Muscle twitching, Muscular weakness, Myalgia
Clinical narrative: Regular shot pain, never went away, needle was put in lower arm, then pulled out, put in again bone was nicked, had 2 MRIs, 1 xray, nerve test, steroids, came back with inflammation. Arthritis in shoulder, neck, foot, injection site is swollen. Received vaccine on October 15 2012 around a week later I was asking how long does it take for the pain of a flu shot to go away because my shot pain was still with me. (October 22 2012). I waited until March 1 2013 to see my family physician only because I had to go see him for my yearly physical. At this time my arm pain was getting worst. It was throbbing all the time and if I moved my arm it would feel like it was getting tired as if I over used it. Sometimes it felt numbness; dull aching pain getting some tingling and I have difficulty with doing simple exercise. Also my left foot was hurting with a persistent pain with aching all the time. Had an x ray. It looked like my bone was nicked as if the person who gave me the shot hit the bone pulled the needle out some and then inserted it in again to finish off the shot. My foot my diagnosis as Morton's neuroma. After seen other doctors. Both said I had arthritis in my shoulder and back of my neck also inflammation in the shoulder. Treatment has a steroid shot in my shoulder. Only helped somewhat. Also arthritis in my foot. As of today August 5, 2013 I am in constant pain in my arm. Also by the site of the injection. I have a constant muscle and joint pain in my arm with sometimes muscle tightness and weakness as an on and off feeling. Once in a while my hand will have a tremor in it if I am holding something. My feet and fingers have a tingling feeling along with a burning sensation in my feet as if I have been standing on them all day. I seem to get to feel a fatigue feeling of wanting to go to sleep at any given time of the day. But yet I have a hard time sleeping (where at one time I was able to fall asleep right away). If my arm is overworked it gets a tired feeling fast and I have to switch to using the other arm. To finish my work. This is ongoing. If I also use the arm too much it getting a swollen effect in the area where the shot was given. In all I cannot sleep on my left arm for more than a 3 minute span. The arm is in constant throbbing pain where sometimes it will start twitching and get tight then gets weak. If someone bumps my arm the pain seems to throb more. So I have burning in my (feet), tingling, tightness, weakness. Fatigue. Swelling, hand tremors, inflammation, arthritis, some anxiety with stress about what is happening to my body because of this shot. It appears that sometimes is going on and my body is not getting any better since the shot.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Stress, Tremor
Clinical narrative: Regular shot pain, never went away, needle was put in lower arm, then pulled out, put in again bone was nicked, had 2 MRIs, 1 xray, nerve test, steroids, came back with inflammation. Arthritis in shoulder, neck, foot, injection site is swollen. Received vaccine on October 15 2012 around a week later I was asking how long does it take for the pain of a flu shot to go away because my shot pain was still with me. (October 22 2012). I waited until March 1 2013 to see my family physician only because I had to go see him for my yearly physical. At this time my arm pain was getting worst. It was throbbing all the time and if I moved my arm it would feel like it was getting tired as if I over used it. Sometimes it felt numbness; dull aching pain getting some tingling and I have difficulty with doing simple exercise. Also my left foot was hurting with a persistent pain with aching all the time. Had an x ray. It looked like my bone was nicked as if the person who gave me the shot hit the bone pulled the needle out some and then inserted it in again to finish off the shot. My foot my diagnosis as Morton's neuroma. After seen other doctors. Both said I had arthritis in my shoulder and back of my neck also inflammation in the shoulder. Treatment has a steroid shot in my shoulder. Only helped somewhat. Also arthritis in my foot. As of today August 5, 2013 I am in constant pain in my arm. Also by the site of the injection. I have a constant muscle and joint pain in my arm with sometimes muscle tightness and weakness as an on and off feeling. Once in a while my hand will have a tremor in it if I am holding something. My feet and fingers have a tingling feeling along with a burning sensation in my feet as if I have been standing on them all day. I seem to get to feel a fatigue feeling of wanting to go to sleep at any given time of the day. But yet I have a hard time sleeping (where at one time I was able to fall asleep right away). If my arm is overworked it gets a tired feeling fast and I have to switch to using the other arm. To finish my work. This is ongoing. If I also use the arm too much it getting a swollen effect in the area where the shot was given. In all I cannot sleep on my left arm for more than a 3 minute span. The arm is in constant throbbing pain where sometimes it will start twitching and get tight then gets weak. If someone bumps my arm the pain seems to throb more. So I have burning in my (feet), tingling, tightness, weakness. Fatigue. Swelling, hand tremors, inflammation, arthritis, some anxiety with stress about what is happening to my body because of this shot. It appears that sometimes is going on and my body is not getting any better since the shot.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Regular shot pain, never went away, needle was put in lower arm, then pulled out, put in again bone was nicked, had 2 MRIs, 1 xray, nerve test, steroids, came back with inflammation. Arthritis in shoulder, neck, foot, injection site is swollen. Received vaccine on October 15 2012 around a week later I was asking how long does it take for the pain of a flu shot to go away because my shot pain was still with me. (October 22 2012). I waited until March 1 2013 to see my family physician only because I had to go see him for my yearly physical. At this time my arm pain was getting worst. It was throbbing all the time and if I moved my arm it would feel like it was getting tired as if I over used it. Sometimes it felt numbness; dull aching pain getting some tingling and I have difficulty with doing simple exercise. Also my left foot was hurting with a persistent pain with aching all the time. Had an x ray. It looked like my bone was nicked as if the person who gave me the shot hit the bone pulled the needle out some and then inserted it in again to finish off the shot. My foot my diagnosis as Morton's neuroma. After seen other doctors. Both said I had arthritis in my shoulder and back of my neck also inflammation in the shoulder. Treatment has a steroid shot in my shoulder. Only helped somewhat. Also arthritis in my foot. As of today August 5, 2013 I am in constant pain in my arm. Also by the site of the injection. I have a constant muscle and joint pain in my arm with sometimes muscle tightness and weakness as an on and off feeling. Once in a while my hand will have a tremor in it if I am holding something. My feet and fingers have a tingling feeling along with a burning sensation in my feet as if I have been standing on them all day. I seem to get to feel a fatigue feeling of wanting to go to sleep at any given time of the day. But yet I have a hard time sleeping (where at one time I was able to fall asleep right away). If my arm is overworked it gets a tired feeling fast and I have to switch to using the other arm. To finish my work. This is ongoing. If I also use the arm too much it getting a swollen effect in the area where the shot was given. In all I cannot sleep on my left arm for more than a 3 minute span. The arm is in constant throbbing pain where sometimes it will start twitching and get tight then gets weak. If someone bumps my arm the pain seems to throb more. So I have burning in my (feet), tingling, tightness, weakness. Fatigue. Swelling, hand tremors, inflammation, arthritis, some anxiety with stress about what is happening to my body because of this shot. It appears that sometimes is going on and my body is not getting any better since the shot.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Local reaction at injection site. Redness and itching.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Reddness and swelling in arm from shoulder to elbow. Started day after admin, 3 days after she went to urgent care, given antibiotic and steroids.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Vasovagal reaction after HPV injection. Seconds of loss of consciousness. All vitals stable.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Vaccine 8/1 to 8/3 noticed erythema and hives at injection site plus hive L cheek and on L arm.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Dysphonia
Clinical narrative: Yesterday evening patient reported hoarseness. Patient told by on-call MD to take BENADRYL which relieved pt's hoarseness.
Age: 1.09
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: 1 yr IZ's given on 7-25-13 = PENTACEL, Hep A, MMR, Pneumo, Hep B.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Loss of consciousness, Mydriasis
Clinical narrative: Within 2 minutes, dizziness. Within 4-5 minutes post injection, LOC for 30-60 seconds. Diaphoretic sweating, clammy, pale, dilated pupils, Recovered within 20-30 minutes fully. EMS evaluation completed and cleared on site.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Within 2 minutes, dizziness. Within 4-5 minutes post injection, LOC for 30-60 seconds. Diaphoretic sweating, clammy, pale, dilated pupils, Recovered within 20-30 minutes fully. EMS evaluation completed and cleared on site.
Age: 6.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 6 year old patient. On 31-JUL-2013 the patient was vaccinated with PROQUAD (Merck), full dose, subcutaneously (lot# and exp date unspecified), and VARIVAX (Merck) full dose subcutaneously (lot# and exp date unspecified). No adverse effects was reported. This is one of two reports from the same reporter. MARRS: 1308USA001878. Patients outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Within 2-3 minutes reports dizziness and stated "I'm going down." Then was lowered to floor with assistance. LOC 30-60 seconds. Return of consciousness with diaphoretic sweating, BP stable. EMS called and evaluated and cleared. Guest was stable at discharge. Fully recovered in 20-30 min.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema
Clinical narrative: Parents notice the pink and redness 4 hours after the vaccine given. Parents gave TYLENOL and few hours after the TYLENOL the pink and redness gone. No more symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a pharmacist concerning an approximately a female patient of unknown age. Pertinent medical history and drug reactions/allergies was unspecified by the reporter. In approximately July 2011, the patient was vaccinated with ZOSTAVAX (dose, duration and lot # not reported). Concomitant therapy was unspecified by the reporter. On an unknown date, reported recently, the patient experienced mild cases of shingles (described as a numb arm) following vaccination with ZOSTAVAX. On an unspecified date, the patient sought medical attention, contacted the pharmacist. Subsequently, on an unspecified date, the patient recovered of mild cases of shingles (described as a numb arm). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose and frequency were not provided) reconstituted with MENACTRA. No adverse effect reported. Follow up information has been received on 29-JUL-2013 from the patient's physician. It was reported that the patient experienced redness and swelling at the injection site 1-3 days after receiving ZOSTAVAX. The patient went to the physician's office yesterday (29-JUL-2013), and she reported the redness and swelling had improved since it initially developed. The patient was prescribed mometasone for symptoms. No other adverse effects reported. At the time of the report the outcome of redness and swelling at the injection site was recovering. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning an unknown number of patients of unspecified gender and age. On an unknown date, an unknown number of "adult asplenic patients were vaccinated with a "pediatric dose" of PEDVAXHIB (dosis, lot # not reported). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: This spontaneous report as received from a female patient of unknown age via a field representative refers to herself. On an unknown date the patient was vaccinated with the first dose in the series of GARDASIL (route was not reported). On an unknown date the patient experienced fatigue, headaches and nausea. At the time of the report, the outcome of fatigue, headaches and nausea was unknown. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to an 85 year old female patient. On 30-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) IM instead of SQ. The pharmacist reported that on 30-JUL-2013, the patient experienced soreness at the injection site. There was no Lab/diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 8 year old male patient who on 05-AUG-2009, was vaccinated with the first dose of GARDASIL and on 31-JUL-2013, was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse events were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dermatitis contact, Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a currently 61 year old female consumer reporting on herself. The patient had no pertinent medical history, drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, route and dose were not specified) injection. No concomitant medications were reported. Consumer reported she experienced a "rash" that "burned and itched" after receiving the ZOSTAVAX. Consumer also stated that she did visit the practicing physician and she was diagnosed with "poison ivy". Consumer stated she was not certain that the rash was from ZOSTAVAX. Consumer was almost convinced that this rash was "poison ivy". Patient received BENADRYL (manufacturer unspecified) (1 pill every 4 hours) as needed as treatment for poison ivy. No lab diagnostics studies were performed. The outcome of poison ivy was not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old patient. On 31-JUL-2013 the patient was vaccinated with PROQUAD (Merck), full dose, subcutaneously (lot# and exp date unspecified), and VARIVAX (Merck) full dose subcutaneously (lot# and exp date unspecified). No adverse effects was reported. This is one of two reports from the same reporter. MARRS: 1308USA002722. Patients outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dyspnoea, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to his/her 17 year old daughter. On 19-JUL-2013 the patient was vaccinated with first dose of GARDASIL (lot number, strength, dose, frequency, indication, route and site unspecified) along with a meningitis vaccine (manufacturer unknown) (lot number, strength, dose, frequency, indication, route and site unspecified). The patient experienced shortness of breath and headache from 24-JUL-2013 to 27-JUL-2013. She began feeling well on 28-JUL-2013. The outcome of shortness of breath and headache was reported as recovered/resolved on 28-JUL-2013. The patient had sought unspecified medical attention. Additional information is not expected.