chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Ocular vascular disorder, Onychoclasis, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received a single dose of PREVNAR 13, via an unspecified route of administration at the age of 73-years on 06Mar2015. Medical history included blood pressure, thyroid disorder and she took levothyroxine for that, diverticulitis from 2013 and she did not take any medication for it. She had that attack in 2013. Concomitant medications included lisinopril, levothyroxine and TYLENOL. The patient might have polymyalgia rheumatica on an unspecified date with outcome of unknown, she had all kind of pain/ache all over on 11Mar2015 with outcome of unknown, shot pain never left in her shoulder but that was minor/pain went on from her elbow to then her shoulder on 11Mar2015 with outcome of not recovered, pain in both arm from her wrist and elbow on 11Mar2015 with outcome of unknown, little bit of stuck blood in her eye on an unspecified date with outcome of unknown, lost her weight around 18 pound on an unspecified date with outcome of unknown, she had gained weight on an unspecified date with outcome of unknown, she got perm in her hair it did not take for first time/hair were like straw on an unspecified date with outcome of unknown, finger nails are short, stubby, break off and now they were in layers on an unspecified date with outcome of unknown, skin was dry on an unspecified date with outcome of unknown, pain in both arm from her wrist and elbow on 11Mar2015 with outcome of unknown. Therapeutic measures were taken as a result of had all kind of pain/ache all over, shot pain never left in her shoulder but that was minor/pain went on from her elbow to then her shoulder, pain in both arm from her wrist and elbow, pain in both arm from her wrist and elbow. The patient mentioned that she went to doctor and they run some blood work in Aug2015. She mentioned that her doctor gave her TYLENOL for discomfort. The patient mentioned that she went to her rheumatologist and he put her on prednisone. She was trying to wean herself off of that because of dangerous effects of that and TYLENOL for the pain she was having from PREVNAR 13. The patient also mentioned that her rheumatologist told her that might be it was polymyalgia rheumatica.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Polymyalgia rheumatica, Weight decreased, Weight increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received a single dose of PREVNAR 13, via an unspecified route of administration at the age of 73-years on 06Mar2015. Medical history included blood pressure, thyroid disorder and she took levothyroxine for that, diverticulitis from 2013 and she did not take any medication for it. She had that attack in 2013. Concomitant medications included lisinopril, levothyroxine and TYLENOL. The patient might have polymyalgia rheumatica on an unspecified date with outcome of unknown, she had all kind of pain/ache all over on 11Mar2015 with outcome of unknown, shot pain never left in her shoulder but that was minor/pain went on from her elbow to then her shoulder on 11Mar2015 with outcome of not recovered, pain in both arm from her wrist and elbow on 11Mar2015 with outcome of unknown, little bit of stuck blood in her eye on an unspecified date with outcome of unknown, lost her weight around 18 pound on an unspecified date with outcome of unknown, she had gained weight on an unspecified date with outcome of unknown, she got perm in her hair it did not take for first time/hair were like straw on an unspecified date with outcome of unknown, finger nails are short, stubby, break off and now they were in layers on an unspecified date with outcome of unknown, skin was dry on an unspecified date with outcome of unknown, pain in both arm from her wrist and elbow on 11Mar2015 with outcome of unknown. Therapeutic measures were taken as a result of had all kind of pain/ache all over, shot pain never left in her shoulder but that was minor/pain went on from her elbow to then her shoulder, pain in both arm from her wrist and elbow, pain in both arm from her wrist and elbow. The patient mentioned that she went to doctor and they run some blood work in Aug2015. She mentioned that her doctor gave her TYLENOL for discomfort. The patient mentioned that she went to her rheumatologist and he put her on prednisone. She was trying to wean herself off of that because of dangerous effects of that and TYLENOL for the pain she was having from PREVNAR 13. The patient also mentioned that her rheumatologist told her that might be it was polymyalgia rheumatica.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 58 years old male patient received PREVNAR 13 on an unknown date in 2015 (4-5 weeks before the report), at single dose. Medical history and concomitant medications were not reported. The reporting pharmacist mentioned that the patient received the vaccine and got really sick, had initial fatigue, headache and achiness. The reporting pharmacist stated that sometimes the patient was "scared" of vaccine and after that he was ok, but then he started feeling really ill, he was admitted to the hospital with no diagnosis. The patient recovered from fatigue. Outcome of the other reported events was unknown.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Electromyogram, Injected limb mobility decreased, Nerve conduction studies, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Unable to move left arm.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test, Syncope
Clinical narrative: Syncope-called 911 classic symptoms; dx at hospital was fear of needles; no meds needed.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash pustular, Varicella post vaccine
Clinical narrative: Rash on torso, upper thighs, legs, and arms. Some pus filled lesions. Confirmed with her doctor that it was an outbreak of chickenpox after the Varicella vaccine.
Age: 0.14
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reactions.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Mobility decreased
Clinical narrative: Injection site not healed; Has trouble moving arm (Does not have full range of motion).
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin wrinkling
Clinical narrative: Noticed skin reaction on opposite arm...not a rash, but wrinkling of skin, like it is crumpled tissue paper. It has progressively spread to other arm, breast area, and now neck. It is not itchy or bothersome.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain upper, Arthralgia, Headache, Nausea
Clinical narrative: Nausea, stomach pain, headache, achy joints.
Age: 52.0
Sex: F
Vaccine: FLUC3, HEPAB, MMR, PPV, TYP
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 48h Significant pain, firm swelling, redness, skin sensitivity at Pneumovax 23 injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling cold, Tremor
Clinical narrative: A couple hours after receiving vaccine, patient got home & sais she was very cold, weak & shaking uncontrollable. She went to bed, woke up & took a TYLENOL & has been fine since then.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site erythema, Administration site swelling, Injection site pruritus
Clinical narrative: Will reconfirm date with pt. Pt. developed swelling and erythema around administration site. At times, pt stated it felt warm. Pt did see a PCP who told her to apply ice packs (date unknown). Some itching at the site. Pt. came to clinic on 9/17/2015. It was noted to be 5.8 x 4.4 erythematous swelling around presumed injection site on right upper arm. Pt. states light itching. It does not feel more warm compared to the rest of the upper arm. Recommend ibuprofen / Benadryl.  Pt. will keep us posted tonight or tomorrow (9/18/2015) regarding reaction.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash erythematous, Rash pruritic, Skin warm, Swelling
Clinical narrative: Two different issues: swellings and rashes, not to be confused with each other. Swellings: Beginning the evening of patient's first MMR shot (the only first-dose vaccine she had that day), she's had sporadic swellings on various areas of her body. The swellings are puffy, sensitive to pressure, and warm/hot to the touch. She can feel them coming with an itchy sensation that goes away once the swelling appears. The swellings typically last for several hours each, with no residual affects apparent. The locations of the swellings do not include joints or lymph node locations, and seem to be surface-level only; they've shown up on her feet, near her wrist, on a finger, around her hips, on her rear end, etc. Rashes: Seperately from the swellings, she also had a rash show up on her thighs three days after the vaccine. The rash waxes and wanes in feel and appearance and is still evident 2 months later. A similar rash came and went on her knees and inside shins, but isn't still visible. The rashes are/were mild ... tiny red dots you can see and feel, itchy.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: Two different issues: swellings and rashes, not to be confused with each other. Swellings: Beginning the evening of patient's first MMR shot (the only first-dose vaccine she had that day), she's had sporadic swellings on various areas of her body. The swellings are puffy, sensitive to pressure, and warm/hot to the touch. She can feel them coming with an itchy sensation that goes away once the swelling appears. The swellings typically last for several hours each, with no residual affects apparent. The locations of the swellings do not include joints or lymph node locations, and seem to be surface-level only; they've shown up on her feet, near her wrist, on a finger, around her hips, on her rear end, etc. Rashes: Seperately from the swellings, she also had a rash show up on her thighs three days after the vaccine. The rash waxes and wanes in feel and appearance and is still evident 2 months later. A similar rash came and went on her knees and inside shins, but isn't still visible. The rashes are/were mild ... tiny red dots you can see and feel, itchy.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lethargy, Rash erythematous
Clinical narrative: Pt started developing multiple red bumps mild lethargy.
Age: 15.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO adverse event. He is 15 year old male received Twinrix. Twinrix is for 18 and older.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Mom noted upon giving child a bath that he has a large red wheal around the site where I injected his MMRV one week ago.  Wheal bright red and measures 45mm X 35mm.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swelling, soreness and bruising around injection site. Swelling lasted for 2-3 days, then subsided.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: The morning of 9/5, right arm was swollen, red, hot to touch, and he had a fever. Swelling progressed from his shoulder to forearm and, by evening, his right arm was 1 1/2 times the size of his left.  Fever went up to 102 degrees F.  Parent administered Tylenol alternating with ibuprofen. Fever was gone by the end of the day 9/7. The swelling began to go down on 9/6.  He had completely recovered by 9/9/2015.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood pressure abnormal, Electroencephalogram abnormal, Incoherent, Seizure, Vomiting
Clinical narrative: Incoherent-seizure. Vomiting. Unstable blood pressure. Husband took her to ER.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Mother could not remember start of symptoms, pruritic rash. Client and mother came to clinic 9/15/15, was referred to urgent care. Went to urgent care 9/15/15 and started on prednisone 20mg pack x 7 days and hydroxyzine 25mg 1 tab daily. On 9/17/15, mother reported improvement from rash.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injected limb mobility decreased in a 47-year-old female patient who received FLUARIX QUADRIVALENT (batch number NJ4PP, expiry date 23rd June 2016). Concomitant products included CYMBALTA, SUDAFED, vitamin D nos, XANAX and ZANTAC. On 4th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular). On 9th September 2015, 5 days after receiving FLUARIX QUADRIVALENT, the patient experienced injected limb mobility decreased and shoulder pain. The patient was treated with MOTRIN. On an unknown date, the outcome of the injected limb mobility decreased was unknown and the outcome of the shoulder pain was unchanged. It was unknown if the reporter considered the injected limb mobility decreased and shoulder pain to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient received a dose of FLUARIX QIV in the left deltoid. On 9th September 2015, the patient experienced left shoulder pain and decreased range of motion of the shoulder. The patient was treated with MOTRIN (800mg) to help her move and for the pain.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 46-year-old male patient who received FLUARIX QUADRIVALENT (batch number 45YJ4, expiry date 16th June 2016). On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced diarrhea. In September 2015, the patient experienced nausea. On an unknown date, the outcome of the diarrhea and nausea were unknown. It was unknown if the reporter considered the diarrhea and nausea to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient stated  that, he was experiencing food poisoning like symptoms. In September 2015, less than a week after receiving FLUARIX QIV, the patient experienced nausea.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Ache/pain of shoulder blade and elbow of arm used for injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Metamorphopsia, Vision blurred, Wheezing
Clinical narrative: Pt had HIGH DOSE flu shot today at 11AM. Developed SOA, wheezing about 1:30 PM. Unresponsive to albuterol inhaler. Chest tightness worsened with, film over eyes and vision distorted prompted call to clinic. Advised to present immediately. Chest tightness, heaviness to lungs progressed in route. No oral swelling. Had been feeling well.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Hot to touch with redness over left deltoid, mildly tender with no other areas of redness.  Pt was seen at Urgent Care 09/15/2015.  Seen in our clinic 09/16/2015 where the redness had decreased in size.  Pt treated with Augmentin and Prednisone.  Also instructed to use topical Hydrocortisone 1% PRN.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Local reaction at injection site nickel sized round red tender surrounded by light bruise about 2 inches diameter and then whole upper arm swollen and light pink and warm to touch progressed to above elbow even up to 30 hours later - relieved a little by ice and feeling better and appearing lighter morning of day 3 with day 1 being day of injection.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Local reaction at injection site nickel sized round red tender surrounded by light bruise about 2 inches diameter and then whole upper arm swollen and light pink and warm to touch progressed to above elbow even up to 30 hours later - relieved a little by ice and feeling better and appearing lighter morning of day 3 with day 1 being day of injection.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Angiogram normal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, pain, sweating and temperature in my upper arm where vaccine was placed. Now unable to raise my hand to my shoulder height, very painful, swollen and unable to sleep.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased, Pain, Swelling
Clinical narrative: Pain, swelling, redness, pain, sweating and temperature in my upper arm where vaccine was placed. Now unable to raise my hand to my shoulder height, very painful, swollen and unable to sleep.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Paraesthesia, Pruritus generalised, Vaccination site warmth
Clinical narrative: PT BEGAN ITCHING ALL OVER BODY, AND THE VACCINATION AREA BEGAN TO BECOME WARM TO THE TOUCH. THE PATIENT THEN STATED THAT THE SIGHT BEGAN TO ITCH MORE SEVERLY. PT STATES THAT THE SIGNS AND SYMPTOMS HAVE WORSENED AND SHE IS BEGINNING TO FEEL "TINGLING" IN THE HAND OF THE ARM THAT THE VACCINE WAS ADMINSTERED. PATIENT TOOK ALEGRA AND BENADRYL THIS MORNING ALONG WITH TOPICAL HYDROCORTISONE. THE PATIENT HAS SCHEDULED AN APPOINTMENT TO BE SEEN BY HER PRIMARY CARE PROVIDER.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: PT STATES THAT SHE STARTED ITCHING AROUND 05:15 AM. THEN AROUND 5:15 PM SHE CAME UP WITH HIVES. PT STATES THAT SHE TOOK BENADRYL AND TOOK A WARM BATH, THEN HIVES DISAPPEARED. PT STATES THAT THE ITCHING HAS ALMOST COMPLETELY STOPPED.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Nodule, Pain in extremity
Clinical narrative: Knot in arm and arm soreness 1 week after shot.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Malaise, Pyrexia, Slow speech
Clinical narrative: Extremely sick with high fever. After a couple days of not talking he began to recover but his speech was slowed and he went from quick efficient speech patterns with multiple syllable words (before illness) to single syllable words and great pauses before speaking his thoughts. He eventually (over the course of months) regained his vocabulary and ability to express himself normally but it was just a different way of talking than he used to..a little more reflective. Grandparents and daycare providers asked about what brought about the change.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Pt presents with swelling on left arm. Swelling started approx 2 inches above elbow. No redness, swelling noted at injection site. Swelling continues to lower arm and all fingers.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Red painful spot around vaccination site.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Cardiac function test, Dizziness, Injection site reaction, Pain, X-ray
Clinical narrative: Pain moving and throbbing up and over my left shoulder and down the front of my arm so severe that I felt faint.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dyspnoea, Heart rate increased
Clinical narrative: Patient described that she experienced chills, elevated heart rate, and shortness of breath after receiving high dose influenza and Prevnar vaccines.
Age: 35.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling and pain around injection site.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Asthenia, Chills, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Swollen right deltoid, warm, no redness, chills, body aches, nausea, weakness.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pain
Clinical narrative: Swollen right deltoid, warm, no redness, chills, body aches, nausea, weakness.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swelling and heat located 2-3 inches below injection site on right arm. Instructed patient to put ice on the area and take Benadryl. If no improvement by tommorrow morning, contact physician.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site swelling
Clinical narrative: 3" red swollen area around the injection site. Headache and generally feeling bad.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Anxiety, Vomiting
Clinical narrative: After vaccine, patient vomited.  Patient was very anxious.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Persistent screaming for the next 3 days.  Acetaminophen, mylicon.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: PT REPORTED TINGLING IN HANDS/FEET/AND LIPS. DID NOT HAVE DIFFICULTY BREATHING OR SWELLING OF TONGUE/MOUTH. DISPENSED LIQUID BENADRYL TO PT FOR ADMINISTRATION AS SOON AS SHE GOT HOME AS SHE INTENDED TO DRIVE AND IT MAKES HER TOO SLEEPY.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Discomfort, Erythema, Pruritus, Skin warm
Clinical narrative: Redness down arm stopping at the elbow. Warm to the touch. Pt C/O itching and mild discomfort. No medications used to alleviate any of the symptoms.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough
Clinical narrative: Cough, felt in the lungs.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient stating that she is having a lot of pain in her right shoulder.  Mentioned that she thought when the vaccine was administered we "hit a nerve" and she could feel it in her hand.  Also received a flu shot in the other shoulder that she says is fine but experiencing a lot of pain in the arm we administered Prevnar.
Age: 36.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Pink red spot about 2 inches wide. Hot and red to touch for about 4 days. Patient did not treat.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Bradycardia, Capillary nail refill test abnormal, Hypopnoea, Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: About 5-10 minutes after the vaccines pt. became hyporesponsive and hypotonic with bradychardia <50 and shallow respirations, appeared pale with cap refill >4s. Pt immediately was brought into room and stimulated with poor response and BVM respirations with O2 given for about 1 minute. Pt's HR, respiration, color and cap refill returned to normal with improved interactivity. 911 called in the meantime and arrived about 10 minutes after initial presentation. By that time pt was doing well.
Age: 42.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Lethargy, Pallor
Clinical narrative: Chills, light headed, pale, lethargic.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperaesthesia, Injection site bruising, Malaise, Nausea
Clinical narrative: Patient calls and says that the evening of vaccination, she wakes up with nausea and vomiting and very sensitive skin to the touch. General malaise and lack of energy continues through the next day. States she has bruise at injection sight.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient calls and says that the evening of vaccination, she wakes up with nausea and vomiting and very sensitive skin to the touch. General malaise and lack of energy continues through the next day. States she has bruise at injection sight.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Tremor
Clinical narrative: Tremor, weakness of extremities.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: Patient felt extremely sleepy for the two days following the immunization, and is still experiencing sleepiness, but not as marked as the first couple days.  Pt states he has received flu immunizations in the past without incident.  Pt requested us to inform his physician, the prescriber and complete a VAERS.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Urticaria, Vaccination complication
Clinical narrative: Patient broke out in a severe case of hives. We called the pediatrician who thought it was a food allergy. When steroids and antihistamines didn't cure the hives, the pediatrician sent me to an allergist. The allergist believes its a delayed immune response to the MMR, an allergic reaction to the vaccination.
Age: 51.0
Sex: F
Vaccine: DTAP, FLU3, PNC13, VARZOS
Symptoms: Dizziness, Pain, Rash, Upper extremity mass
Clinical narrative: Softball sized rash and lump on patient's arm below the injection site that spread to her forearm. She states that it is painful and she is starting to get dizzy. I recommended Benadryl but patient said she had been taking it already and it was not helping.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Patient stated "I had severe stomach pain". "I went to ER and they gave me a cocktail and made my throat numb." "I stopped the vaccine and all my symptoms went away."
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Nausea, dizziness, diarrhea, headache--got worse as day went on. Took Excedrin and Tums and went home and slept for 3 hours at about 12:30 pm. Felt better once I woke up.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Insomnia, Pyrexia, White blood cell count increased
Clinical narrative: Begin feeling feverish, didn't sleep due to fever all night. 9/14/2015 at 1:00 PM fever and chills, checked temp and it was 104 degrees. Went to urgent care and it was 104 there as well. Fever broke 9/15/2015 AM.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Disorientation, Drooling, Erythema, Eye movement disorder, Hyperhidrosis
Clinical narrative: Administered HPV 9 Lot number L006547 into the patients right deltoid. Pt appeared fine and talked freely to her sister for 1-2 minutes after receiving the injection, while sitting on the exam table.  Pt stated she felt fine and moved from the exam table to the chair approximately 5-10 steps away.  Pt continued talking for a short time possiblly 1 minute then stated she did not feel well.  Pt's head fell back and eyes rolled back, pt was unresponsive to touch or sound. Her face turned red and pt began to drool. Her body became stiff and rigid.  With assisstance was able to maneuver pt to a sitting position on the floor.  Pt seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered pt to a supine position on the floor with both legs lifted pt came to and was quickly oriented.  Her coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the pt.  Pt remained on the floor for approximately 10 min then was able to sit up and drink gatorade and eat crackers.  Remained in sitting position on the floor for another 5-7 minutes before standing up.  Pt was still shaky but was feeling better.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Muscle rigidity, Musculoskeletal stiffness, Mydriasis, Pallor
Clinical narrative: Administered HPV 9 Lot number L006547 into the patients right deltoid. Pt appeared fine and talked freely to her sister for 1-2 minutes after receiving the injection, while sitting on the exam table.  Pt stated she felt fine and moved from the exam table to the chair approximately 5-10 steps away.  Pt continued talking for a short time possiblly 1 minute then stated she did not feel well.  Pt's head fell back and eyes rolled back, pt was unresponsive to touch or sound. Her face turned red and pt began to drool. Her body became stiff and rigid.  With assisstance was able to maneuver pt to a sitting position on the floor.  Pt seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered pt to a supine position on the floor with both legs lifted pt came to and was quickly oriented.  Her coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the pt.  Pt remained on the floor for approximately 10 min then was able to sit up and drink gatorade and eat crackers.  Remained in sitting position on the floor for another 5-7 minutes before standing up.  Pt was still shaky but was feeling better.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Posture abnormal, Tremor, Unresponsive to stimuli
Clinical narrative: Administered HPV 9 Lot number L006547 into the patients right deltoid. Pt appeared fine and talked freely to her sister for 1-2 minutes after receiving the injection, while sitting on the exam table.  Pt stated she felt fine and moved from the exam table to the chair approximately 5-10 steps away.  Pt continued talking for a short time possiblly 1 minute then stated she did not feel well.  Pt's head fell back and eyes rolled back, pt was unresponsive to touch or sound. Her face turned red and pt began to drool. Her body became stiff and rigid.  With assisstance was able to maneuver pt to a sitting position on the floor.  Pt seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered pt to a supine position on the floor with both legs lifted pt came to and was quickly oriented.  Her coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the pt.  Pt remained on the floor for approximately 10 min then was able to sit up and drink gatorade and eat crackers.  Remained in sitting position on the floor for another 5-7 minutes before standing up.  Pt was still shaky but was feeling better.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Cough, Fatigue, Pyrexia
Clinical narrative: On 9/17/15, The Patient stated on 9/15/15 at 12:30am she experienced chest pain and severe coughing all night, then after those effects subsided she had a fever and chills all day on 9/15/15, then fatigue and slept all day 9/15/15 and 9/16/15. She called her doctor and had a checkup on 9/17/15 in which the physician prescribed an antibiotic if symptoms worsened.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Needle issue
Clinical narrative: Needle malfunctioned on retractable needle while giving flu shot, and the needle came off the syringe. Vaccine spilled down patient's arm. Patient had no harm, and was given a second flu vaccine.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Redness near the injection site. Underneath the site on the upper left arm.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Contusion, Pain, Pruritus, Rash erythematous
Clinical narrative: C/O rash, itching, redness and erythema involving neck, abdominal area, chest and trunk area.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Generalised erythema, Pruritus generalised, Rash generalised
Clinical narrative: C/O rash, itching, redness and erythema involving neck, abdominal area, chest and trunk area.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itchyness, redness, and warmth to injection site; BENADRYL OTC PRN.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch at injection site.
Age: 73.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Large area of erythema & warmth extending from AC joint, 3 cm in width medially down arm to 3" above medial elbow.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain in extremity, Skin warm
Clinical narrative: Patient reported left arm was warmer & hda a "knot" & sore.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Dermatitis allergic
Clinical narrative: Dx: Allergic derm reaction
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Pt experienced numbness from wlbow to wrist around noon time. By 2.30pm he was fine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Nausea, vomiting, HA, redness and swelling at injection site. Treated with TORADOL, ZOFRAN.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, HA, redness and swelling at injection site. Treated with TORADOL, ZOFRAN.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Rash pruritic
Clinical narrative: Itching diffuse rash started 1 day ago. It is constant in duration. It is worse. Its aggravated by scratching.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Choking, Cough, Headache, Nausea
Clinical narrative: Received FLUZONE High Dose 0.5 ml IM close to noon on 9/11/15. Waited in pharmacy about 15 mins to see patient. No problems. She went home ate lunch, then suddenly felt feverish, headache, stomach ache and nausea. She hell as propped up at 45 degree angle and woke up choking due to plegery, fasting food. Lot of irritation (in throat) and coughing thru Sunday. Feeling better now. Patient called (Dr-Not sure if directly related to Flu shot).
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Received FLUZONE High Dose 0.5 ml IM close to noon on 9/11/15. Waited in pharmacy about 15 mins to see patient. No problems. She went home ate lunch, then suddenly felt feverish, headache, stomach ache and nausea. She hell as propped up at 45 degree angle and woke up choking due to plegery, fasting food. Lot of irritation (in throat) and coughing thru Sunday. Feeling better now. Patient called (Dr-Not sure if directly related to Flu shot).
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aspiration, Asthenia, Cough, Dyspnoea, Headache
Clinical narrative: Received FLUZONE High Dose 0.5 ml IM close to noon on 9/11/15. Waited in pharmacy about 15 mins to see patient. No problems. She went home ate lunch, then suddenly felt feverish, headache, stomach ache and nausea. She hell as propped up at 45 degree angle and woke up choking due to plegery, fasting food. Lot of irritation (in throat) and coughing thru Sunday. Feeling better now. Patient called (Dr-Not sure if directly related to Flu shot).
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Received FLUZONE High Dose 0.5 ml IM close to noon on 9/11/15. Waited in pharmacy about 15 mins to see patient. No problems. She went home ate lunch, then suddenly felt feverish, headache, stomach ache and nausea. She hell as propped up at 45 degree angle and woke up choking due to plegery, fasting food. Lot of irritation (in throat) and coughing thru Sunday. Feeling better now. Patient called (Dr-Not sure if directly related to Flu shot).
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: The patient developed rash on neck/back and breast and face. It started 10 min after rash. It worsened over 3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified patient of unknown age and gender. On 15-SEP-2015, the patients was vaccinated with an improperly stored dose of VARIVAX (lot # L008269, expiration date 11-MAR-2017, dose and route were unknown). No adverse effects reported. No PQC involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. Between the date of 02-MAR-2015 to August 2015, the patients were vaccinated with doses of improperly stored ROTATEQ (lot# K016311 with expired date 26-MAY-2016, oral, dose was unknown). No concomitant medication was provided. No adverse effect was reported. This is one of two reports received from the same reporter (1509USA004806). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two unspecified patients of unknown age and gender. On 14-SEP-2015, the patients were vaccinated with an improperly stored dose of PROQUAD (lot # L008355, expiration date 11-SEP-2016, dose and route were unknown) separately. No adverse effects reported. No PQC involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia, Rash erythematous, Rash macular, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a care coordinator nurse practitioner (who works in the physician's office) via a company representative and refers to an 81 year old female patient. The patient's concurrent conditions, medical history were not provided. On 05-SEP-2015, the patient was vaccinated with PNEUMOVAX23 (lot, batch no # K008410, expiry date 26-FEB-2016, 1 vial) at an unspecified long term care facility. The patient was on unspecified concomitant medication. On an unknown date, the patient developed pea size red spots on her skin (unspecified location) (rash macular), runny nose (rhinorrhea) fever (pyrexia), did not feel well in general (malaise). The patient left the care facility on an unspecified date. The patient visited the physician's office and sought medical attention. The outcome of the events rhinorrhea, malaise, pyrexia and rash macular was unknown. Product quality complaint (PQC) was not reported. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Allergy test, Angioedema, Blood immunoglobulin E, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate redness and hives to surrounding area then large confluent hive/angioedema like (L) thigh at injection site.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site reaction, Injection site urticaria
Clinical narrative: Immediate redness and hives to surrounding area then large confluent hive/angioedema like (L) thigh at injection site.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Student had varicella vaccine as required by med school program. Redness, swelling, warmth, itching at site of injection that increased over a few days. Arthus rxn vs. infection? Pt. seen by provider who prescribed CIPRO and instructed pt to RTC with any additional symptoms or worsening of symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a 66 year old female patient who was involved in a Market research project referring to herself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with one dose of pneumococcal vaccine (manufacturer unknown)(lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date, the patient experienced unspecified adverse event. She was hospitalized on an unknown date and almost died. The outcome of the event was unknown. The causality between the event and pneumococcal vaccine (manufacturer unknown) was not reported. Additional information is not expected because the reporter was not consented to be contacted.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No none adverse event. Pt received ZOSTAVAX when she was supposed to receive FLUZONE High Dose. Pt and MD made aware. (Pt had not received ZOSTAVAX in past, nor had any contraindication).
Age: 0.2
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a 2 month old patient. On 08-SEP-2015, the patient was inadvertently vaccinated with GARDASIL (confirmed not GARDASIL 9), dose, frequency and lot number not provided instead of LIQUID PEDVAXHIB. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from  a registered medical assistant referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 12-MAY-2015, multiple unspecified patients were vaccinated with unspecified doses of improperly stored LIQUID PEDVAXHIB (lot # K004541, expiry date 04-DEC-2016) (dosage, strength and route were not reported). At the time of the report, there was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Left upper forearm erythema, warm, tender to touch non-edematous. Sx began day after injection.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-AUG-2015, the patient was vaccinated with the improperly stored VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On 09-SEP-2015, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (lot# L011846, expiration date 16-JUN-2017, strength, dose and route unknown). No adverse events had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a few patients of unknown age and gender. On unknown dates, these patients were vaccinated with ZOSTAVAX (dose, frequency and lot# were not reported). On unknown dates these patients experienced shingles after receiving ZOSTAVAX. The outcome of the event was unknown. Causality was not reported. It was unspecified if these patients sought medical attention or not. Additional information is not expected because the physician would not like to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 09-SEP-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L003777, expiration date 04-FEB-2017, dose and route were not reported). Concomitant drug was not reported. No adverse reactions were reported. This is one of the two reports from the same reporter. Addditional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 60 years old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 02-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010630, expiration date 30-OCT-2015) (dose and route were not reported). Concomitant drug was not reported. In a couple of days after the injection (on an unknown date in September 2015), the patient developed a red, itchy rash at the injectionn site. On 11-SEP-2015, the patient spoke with the pharmacist and the red, itchy rash was still present. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-SEP-2015, the patient was vaccinated with the improperly stored VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 14-SEP-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K010016, expiration date: 05-AUG-2015; dose not reported) subcutaneously (expired product administered). No known adverse effects were reported. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Fever 103 (12 hrs post vaccination) dizziness, nausea. Pt received PNEUMOVAX-23 (9/16/15).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. Between the dates of 02-MAR-2015 to August 2015, the patients were vaccinated with doses of improperly stored M-M-R II (lot# was K015375 with expired date 18-SEP-2016, dose and route were unknown). No concomitant medication was provided. No adverse effect was reported. This is one of two reports received from the same reporter (1509USA004852). Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program conducted, refers to an 86 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose 1; dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced injection site reaction and a square rash. The reporter stated that she/he believed age to the factor and that she/he never gave it to the oldest patients. The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Dermatitis allergic
Clinical narrative: Possible allergic dermatitis to chicken pox vaccine.