chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Face injury, Fall, Head injury, Laceration, Lip injury
Clinical narrative: Pt passed out and hit her head. She did lose consciousness.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out and hit her head. She did lose consciousness.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Oral discomfort, Palpitations, Tongue disorder
Clinical narrative: Patient became flushed in the face, felt hot, heart was racing and felt as though her mouth and tongue felt thick (not completely swollen and patient was able to continue to breathe).
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Computerised tomogram head, Hypoaesthesia, Lumbar puncture, Muscular weakness
Clinical narrative: Sudden onset of pain and breathing from her right hip to right anterior thigh, down to her right foot with numbness, tingling, and weakness to her right lower extremity.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Painful respiration, Paraesthesia
Clinical narrative: Sudden onset of pain and breathing from her right hip to right anterior thigh, down to her right foot with numbness, tingling, and weakness to her right lower extremity.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Gait disturbance, Headache, Pain, Pyrexia
Clinical narrative: Chills and headache at 2:30 PM. At 6:00 PM experienced fever of 100.6, body aches, chills and extreme overall trembling (Rigors) which prevented me from walking normally. Took Tylenol for fever, aches and trembling. About midnight the trembling began again; I called the Dr. on call at my medical facility to see if I should call 911; she said I was suffering from "rigors" and should alternate Tylenol and Ibuprofen for the chills and rigors; continued with the Tylenol and Ibuprofen for aches and fever through Oct. 12. I felt better the morning of Oct. 13 but the 100.4 fever returned at 6:15PM; took Ibuprofen. I felt better the morning of Oct. 14 but a 100.2 fever returned at 4:30PM; took Ibuprofen. I felt better on Oct. 15 and and the fever did not return. I have never received the Fluzone High-Dose injection until this year. The pharmacist said it had better protection for people over 65. I will NEVER get that injection again!!!
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Chills and headache at 2:30 PM. At 6:00 PM experienced fever of 100.6, body aches, chills and extreme overall trembling (Rigors) which prevented me from walking normally. Took Tylenol for fever, aches and trembling. About midnight the trembling began again; I called the Dr. on call at my medical facility to see if I should call 911; she said I was suffering from "rigors" and should alternate Tylenol and Ibuprofen for the chills and rigors; continued with the Tylenol and Ibuprofen for aches and fever through Oct. 12. I felt better the morning of Oct. 13 but the 100.4 fever returned at 6:15PM; took Ibuprofen. I felt better the morning of Oct. 14 but a 100.2 fever returned at 4:30PM; took Ibuprofen. I felt better on Oct. 15 and and the fever did not return. I have never received the Fluzone High-Dose injection until this year. The pharmacist said it had better protection for people over 65. I will NEVER get that injection again!!!
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Headache, Immediate post-injection reaction, Neck pain
Clinical narrative: States that the left side of her neck and head began "throbbing" immediately after the vaccine was administered and continued for 2 days. Three days after the vaccine was given she began having severe pain in her left hip to the point that she could not walk on her left leg. She went to an orthopedic doctor at that time. The doctor performed xrays of the left hip and found no abnormalities. He then injected her with a steriod injection and placed her on a Solumedrol dose pack. Patient states that she has no proir history of left hip pain, nor has she injured her left hip in any way. Denies any numbness in the left leg.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray of pelvis and hip normal
Clinical narrative: States that the left side of her neck and head began "throbbing" immediately after the vaccine was administered and continued for 2 days. Three days after the vaccine was given she began having severe pain in her left hip to the point that she could not walk on her left leg. She went to an orthopedic doctor at that time. The doctor performed xrays of the left hip and found no abnormalities. He then injected her with a steriod injection and placed her on a Solumedrol dose pack. Patient states that she has no proir history of left hip pain, nor has she injured her left hip in any way. Denies any numbness in the left leg.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Patient called pharmacy on 10.19.2015 @ 2:30 pm, stating that his arm was VERY sore, and that it felt like it was about to "fall off" when he touched it. He also said his "entire body" was sore, and that he could not get out of bed. He compared the pain to that of rotator cuff surgery.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Lump, swelling and pain occurred at the injection site. Came by pharmacy on 10-19-15 to have me look at lump. Stated pain and swelling have gone down.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt states her arm got sore and red and swollen and a little warm.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pharyngeal oedema, Seizure, Unresponsive to stimuli
Clinical narrative: Throat began swelling, took Benadryl and had seizure (as reported by sister) and was unresponsive.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Malaise, Peripheral swelling
Clinical narrative: He called and said he felt ill.  I said that He should rest and maybe consider seeing a physician.  I told him it was possible that it was coincidental.  He just came in here to show me his arm.  It is still quite red and swollen.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Patient indicates he got up very sick to his stomach and as day progressed felt weak. Oct 18 2015 felt better but weak and on Oct 19 2015 he was experiencing dizziness.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt report itching and redness around the site of injecton, still had the itching. Pt states not bad just irritating.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain in right arm radiating down entire arm to fingers with tingling in arm at times. C/o 10/10 pain. Seen by Doctor on 16 Oct 2015 and treated symptomatically. No redness, no swelling at injection site. No fever.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in right arm radiating down entire arm to fingers with tingling in arm at times. C/o 10/10 pain. Seen by Doctor on 16 Oct 2015 and treated symptomatically. No redness, no swelling at injection site. No fever.
Age: 0.75
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Irritability, Respiratory tract congestion, Rhinorrhoea, Vomiting
Clinical narrative: Child not acting like herself. Extremely irritated, fussy, runny nose, congestion, vomiting.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Extremely severe, sharp, deep pain in arm around injection site; deltoid pain continues to spread around injection site over two weeks later.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Throat tightness
Clinical narrative: Patient felt some tightening in throat area, but no difficult breathing. Over the next 24 hours, the tightening continued and patient completely lost voice (even whispering was difficult). No other symptoms of cold or illness noted (no fever, sore throat, congestion, runny nose, body aches, fatigue, etc). This symptoms slowly started to resolve on 10/16, and patient is about 80% recovered today 10/19.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Patient developed rash and hives after receiving the Fluvirin vaccine. Recommended that patient start taking oral diphenhydramine to treat allergic reaction.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site soreness, swelling, and redness.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Erythema, Hypersensitivity, Nausea, Pain in extremity
Clinical narrative: Within 2 hours of receiving shot her arm and shoulder started burning.  By that evening her entire arm was sore.  The next morning she had nausea and vomited twice.  She had a fever of < 100 degrees.  The following day she had no more nausea but still had severe pain in her arm.  The third day after the shot her entire arm turned red and she went to her doctor.  Now, all symptoms have resolved.  Her physician told her that most likely she had an allergic reaction to one of the vaccine components.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Within 2 hours of receiving shot her arm and shoulder started burning.  By that evening her entire arm was sore.  The next morning she had nausea and vomited twice.  She had a fever of < 100 degrees.  The following day she had no more nausea but still had severe pain in her arm.  The third day after the shot her entire arm turned red and she went to her doctor.  Now, all symptoms have resolved.  Her physician told her that most likely she had an allergic reaction to one of the vaccine components.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient described soreness and tenderness at the injection site starting the date of injection and progressively worsen to soreness of the entire left arm.  The site of injection is no longer sore as of 10/19/15 but her left shoulder and arm range of motion is decresed.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: FACE SWELLING.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Influenza like illness, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Right arm (site of administration) started to hurt mid-afternoon on Thurs the day of administration and was Very painful by the evening. Pt did not have use of her arm for 2 days, but when I contacted her Monday morning she felt like she had 1/2 use of it. Pt also had some flu like symptoms, which had mostly resolved, but was still feeling dizzy and lightheaded Monday morning. She did not seek medical attention, but reported severe pain that felt "like her joint was separating". Still painful to raise further that elbow level. Pt took Tylenol for the pain.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Hypotonia, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient experienced limpness in her right arm approximately 2 hours after receiving her Pneumovax 23 vaccination.  Her arm then began to feel excruciating pain and she could not sleep all night.  She went to urgent care the next day and the doctor prescribed her a short course of low dose steroids.  This did not help.  She missed two days of work since her are was in pain and limp and she could not dress herself.  The urgent care doctor ruled out infection and completed an xray.  No new information was gained.  Next, patient went to her primary care physician and started another course of steroids.  She is now seeking physical therapy.  At this date, her arm still hurts.  It is improved but not normal.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Patient experienced limpness in her right arm approximately 2 hours after receiving her Pneumovax 23 vaccination.  Her arm then began to feel excruciating pain and she could not sleep all night.  She went to urgent care the next day and the doctor prescribed her a short course of low dose steroids.  This did not help.  She missed two days of work since her are was in pain and limp and she could not dress herself.  The urgent care doctor ruled out infection and completed an xray.  No new information was gained.  Next, patient went to her primary care physician and started another course of steroids.  She is now seeking physical therapy.  At this date, her arm still hurts.  It is improved but not normal.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, slighly swollen, sore and hot.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Violent vomiting every 20 minutes for approximately 8 hours.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash erythematous
Clinical narrative: A bumpy rash appeared on my face, down my neck and onto my torso; later, tiny red spots appeared all over my chest. This went away after about 2 days.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: 101 F fever after 650 mg aspirin administered at 5 pm.
Age: 37.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Chills, Nausea, Pyrexia, Skin warm
Clinical narrative: Swelling, warmth, fever, nausea, chills,diagnosed on 10/19/2015 with cellulitis and treated with Keflex and prednisone.
Age: 37.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Swelling, warmth, fever, nausea, chills,diagnosed on 10/19/2015 with cellulitis and treated with Keflex and prednisone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Dizziness, Dyspnoea, Neuropathy peripheral
Clinical narrative: Pt called with dizziness and shortness of breath. Went to ER and was admitted for observation.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dysarthria, Familial periodic paralysis, Feeling abnormal, Monoplegia
Clinical narrative: This 62 year old employee works as computer specialist and sent to clinic for evaluation of reported adverse reactions to 2014 flu vaccines in relationship to ongoing health issue to include Hypokalemic Periodic paralysis (HOKPP). She advised she had no adverse events with influenza vaccines every other year from 2007 to 2011. In 2013 she received 2 flu shots, one in Feb and the other in Sept. She recalls feeling weak and foggy brained however she had just been diagnosed with HOKPP in August 2012 with these symptoms being similar to her HOKPP symptoms. On Oct 29, 2014 she again received her annual flu vaccination. She denied being ill and stated she had had no HOKPP symptoms for 9 months. Approximately 5 days later she stated she felt a throbbing sensation to left clavicle region (which is her signal of an attack) then weakness-paralysis to left arm/hand that progressed to include weakness to right arm, slurred speech and foggy brained. She advised she self treated with oral potassium (bananas, Brussels sprouts, etc) and physical symptoms typically resolving in <24 hours and mental issues resolving in 3 days. Past HOKPP symptoms would show resolution of physical symptoms in 2-7 hours with mental issues lasting up to 20 hours. She did f/u with her neurologist who researched and they determined the only new event/change in pattern was receipt of the flu vaccine. She also recalls she was instructed to increase her vitamin D the month before due to low levels. She reports experiencing up to 64 HOKPP episodes in last 21 years described as "strokes" with last event in Sept 2015 with cardiology stress test (triggered by drug induced adrenaline response). She requests consult with office to discuss how vaccines affect the use of potassium in the body and if she'll have another episode of HOKPP following the flu vaccination. She did receive a Tetanus diphtheria vaccination in May 2015 following a cut in ER in which she had no adverse reaction to. No other vaccines have been given/received in >10 years.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain
Clinical narrative: This 62 year old employee works as computer specialist and sent to clinic for evaluation of reported adverse reactions to 2014 flu vaccines in relationship to ongoing health issue to include Hypokalemic Periodic paralysis (HOKPP). She advised she had no adverse events with influenza vaccines every other year from 2007 to 2011. In 2013 she received 2 flu shots, one in Feb and the other in Sept. She recalls feeling weak and foggy brained however she had just been diagnosed with HOKPP in August 2012 with these symptoms being similar to her HOKPP symptoms. On Oct 29, 2014 she again received her annual flu vaccination. She denied being ill and stated she had had no HOKPP symptoms for 9 months. Approximately 5 days later she stated she felt a throbbing sensation to left clavicle region (which is her signal of an attack) then weakness-paralysis to left arm/hand that progressed to include weakness to right arm, slurred speech and foggy brained. She advised she self treated with oral potassium (bananas, Brussels sprouts, etc) and physical symptoms typically resolving in <24 hours and mental issues resolving in 3 days. Past HOKPP symptoms would show resolution of physical symptoms in 2-7 hours with mental issues lasting up to 20 hours. She did f/u with her neurologist who researched and they determined the only new event/change in pattern was receipt of the flu vaccine. She also recalls she was instructed to increase her vitamin D the month before due to low levels. She reports experiencing up to 64 HOKPP episodes in last 21 years described as "strokes" with last event in Sept 2015 with cardiology stress test (triggered by drug induced adrenaline response). She requests consult with office to discuss how vaccines affect the use of potassium in the body and if she'll have another episode of HOKPP following the flu vaccination. She did receive a Tetanus diphtheria vaccination in May 2015 following a cut in ER in which she had no adverse reaction to. No other vaccines have been given/received in >10 years.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash macular, Throat irritation, Tongue pruritus
Clinical narrative: This 40 year old female nurse received annual flu vaccine at 1045am. She reported approximately 5 min after receipt of FLUARIX, her tongue and throat began to itch. She returned to the immunization clinic where she was walked down to ER with a sporadic macular rash to her right elbow and forearm (not at injection site). She denied any difficulty swallowing, breathing, or tightness in throat. She arrived in ER (1117am - seen by triage nurse 1131am and MD at 1142 hr (1 hour after vaccination)) with c/o right arm rash, and itching to face. While she denied any SOB, her exam identified mild bilateral expiratory wheezing with mild urticaria to right arm/elbow and forearm. BP 155/99, HR 78, RR 18 O2 sat 99% rm air, pain 0/10. She was treated with IV antihistamines (BENADRYL 25 mg IVP and PEPCID 20 mg/50 cc NS), IV steroids (DECADRON 8 mg IVP), 250 cc NS bolus and 2 Albuterol HHN with resolution of all symptoms. She was sent home with oral BENADRYL and ZANTAC which she used for next 3 days w/o return of symptoms. (NOTE: ER record documents first left then right arm hives/rash with MD documenting only right arm urticaria and nurses notes documenting rash to right arm and hives on left -- pt states had rash/urticaria to right arm and face, not left arm).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Wheezing
Clinical narrative: This 40 year old female nurse received annual flu vaccine at 1045am. She reported approximately 5 min after receipt of FLUARIX, her tongue and throat began to itch. She returned to the immunization clinic where she was walked down to ER with a sporadic macular rash to her right elbow and forearm (not at injection site). She denied any difficulty swallowing, breathing, or tightness in throat. She arrived in ER (1117am - seen by triage nurse 1131am and MD at 1142 hr (1 hour after vaccination)) with c/o right arm rash, and itching to face. While she denied any SOB, her exam identified mild bilateral expiratory wheezing with mild urticaria to right arm/elbow and forearm. BP 155/99, HR 78, RR 18 O2 sat 99% rm air, pain 0/10. She was treated with IV antihistamines (BENADRYL 25 mg IVP and PEPCID 20 mg/50 cc NS), IV steroids (DECADRON 8 mg IVP), 250 cc NS bolus and 2 Albuterol HHN with resolution of all symptoms. She was sent home with oral BENADRYL and ZANTAC which she used for next 3 days w/o return of symptoms. (NOTE: ER record documents first left then right arm hives/rash with MD documenting only right arm urticaria and nurses notes documenting rash to right arm and hives on left -- pt states had rash/urticaria to right arm and face, not left arm).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever increased 101.2 w/ generalized rash. Fever noticed after going home from work. Rash on abd after working out on 10/14/15, then noticed on arms/legs (BLE and BUE).
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Fever chills (severe) temp 102 happened evening of shot.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Patient came in pharmacy to report that the night after she got her ZOSTAVAX vaccine (vaccine administered at 2:10 pm) her injection site has swollen up a little and it got larger the following day and also the soreness. However, she said it gets better today.
Age: 1.88
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pharyngitis, Pyrexia
Clinical narrative: Fever starting Saturday (10/17/15) to Sunday. Pt had febrile seizure 10/18/15 at 1630pm. Dx: pharyngitis at ED. Tmax 104.0. Given ROCEPHIN, MOTRIN, and ZITHROMAX.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Presyncope, Syncope, Vomiting
Clinical narrative: Pt fainted about 5 seconds after HAVRIX. Received influenza on same visit prior to HAVRIX (FLUVIRIN) (VASOVAGAL). Pt received water and threw up. Pt. fully recovered after 30 minutes and was released from pharmacy.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia, Rash pruritic
Clinical narrative: Client received flu shot on 10/8/15. The following day 10/9/15, client reported having loose stools x 3 which resolved on it's own. On 10/10/15, client developed itchy, scattered rashes on her chest and bilateral upper extremities and a slight fever of 99.0F. She took 25 mg BENADRYL PO at home on 10/10/15 for the rashes which resolved by 10/12/15.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, HEPA, PNC13
Symptoms: Injection site joint swelling
Clinical narrative: Patient had diffuse swelling of right knee and thigh 24 hrs after vaccine - PENTACEL/Hep A.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discolouration, Injection site irritation
Clinical narrative: Localized irritation and discoloring (red, black, blue) at site of injection. Patient took 1 dose of TYLENOL for discomfort.
Age: 16.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving dose of GARDASIL.
Age: 12.0
Sex: M
Vaccine: FLUN4, TDAP
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Rec'd LAIV on 10/15/15, developed stuffy nose. 10/18/15 developed sore throat, headache, fever 104. Fever approximately 101 with MOTRIN. Is taking fluids okay.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Rec'd LAIV on 10/15/15, that ngiht developed fever 103, sore throat, body aches, headaches. Lasted 1-2 days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Patient's arm became very sore and had radiating pain in her chest. Patient made appt with her PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Rash
Clinical narrative: From injection on. Two days (10/15th-10/16th) redness, itching, painful, swelling, rash. Unsuccessful in getting pharmacist to talk to me via pharmacy telephone. Prescribed (3) new prescriptions. Instructed to see PCP/or return to ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: From injection on. Two days (10/15th-10/16th) redness, itching, painful, swelling, rash. Unsuccessful in getting pharmacist to talk to me via pharmacy telephone. Prescribed (3) new prescriptions. Instructed to see PCP/or return to ER.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient received flu shot Saturday 10/17/2015 at 10AM. Mom states child came to her Saturday noc c/o arm soreness. When she looked left deltoid area was red, warm to touch and swollen. Gave dose of BENADRYL. Mom reports arm less swollen today but still red. Appt made to see Doctor. Red localized reaction to (L) arm 7 inches long by 4 inches wide. No antibiotics prescribed.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Body temperature increased, Full blood count normal, Influenza virus test negative, Seizure
Clinical narrative: On 10/15.15 at approximately 5 pm, patient received the influenza vaccine. One hour after vaccine, he had a generalized seizure lasting 15 min. During the seizure, mother took child to urgent care center where his temperature was 103 degrees axillary.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Streptococcus test negative
Clinical narrative: On 10/15.15 at approximately 5 pm, patient received the influenza vaccine. One hour after vaccine, he had a generalized seizure lasting 15 min. During the seizure, mother took child to urgent care center where his temperature was 103 degrees axillary.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Patient has sore arm. It has been 5 days since vaccination. Sore, redness, painful to touch.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Amnesia, Dizziness, Drug screen negative, Full blood count normal, Metabolic function test normal
Clinical narrative: Patient complained of dizziness while lying down 10 min after receiving HPV vaccine and had transient memory loss for about 20 minutes. He remained responsive but would not answer simple questions. He improved, went home, presented to the ER 10 hours later with memory loss again, resolved and sent home.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: NKA, administered IM instead of SubQ.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Induration, Local swelling, Pain
Clinical narrative: Patient was vaccinated on 10/16/2015 about 1:00-2:00pm. Patient started to feel symptoms the moment after the vaccination; the patient mentions like a tingling that went up the upper part of the back. Also had area swollen, red, warm and hardened with pain that extended to the wrist. Patient was went to doctor and antibiotics were prescribed.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Skin warm
Clinical narrative: Patient was vaccinated on 10/16/2015 about 1:00-2:00pm. Patient started to feel symptoms the moment after the vaccination; the patient mentions like a tingling that went up the upper part of the back. Also had area swollen, red, warm and hardened with pain that extended to the wrist. Patient was went to doctor and antibiotics were prescribed.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Eyelid function disorder, Facial paresis, Injection site erythema, Injection site pain
Clinical narrative: Redness pain at site given the day after. Left side of face weakness with hard time to close left eye and liquid came out of opposite corner of mouth when drinking. Two days after Iz.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at injection site low grade temp (Lt) deltoid.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Patient received PENTACEL, PCV13 and rotavirus at 10:15 am on 10/7/15. Approximately at 4:15 mom brought patient back in crying unconsolably for approx 2-3 hr.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Spoke with mother on phone. Patient has been crying non-stop for last hour. Spoke with mom at 5:00 pm - pt has started to settle down - less crying.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle fatigue, Muscular weakness
Clinical narrative: Muscle fatigue/weakness.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling to left thigh, given BENADRYL.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Decreased appetite, Erythema, Local swelling, Mobility decreased
Clinical narrative: Pt. started having aches and pain about 5 hours after shots. Temp 103. Loss of appetite. Pain in joints. Could not lift herself out of chair. Swelling and redness in L arm 5 inches x 3 inches in size.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: Pt. started having aches and pain about 5 hours after shots. Temp 103. Loss of appetite. Pain in joints. Could not lift herself out of chair. Swelling and redness in L arm 5 inches x 3 inches in size.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored PNEUMOVAX 23, (dose and route not provided) (lot number K019933, expiration date: 20-APR-2016 or lot number K020215, expired date 15-MAY-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an adult male patient in his 50's. Information regarding relevant medical history and concomitant condition were not reported. Approximately on an unknown date in 2013 (reported as "2 years ago"), the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). Information regarding concomitant medications was not reported. It was reported that the patient broke out in a mild shingles like rash shortly after receiving ZOSTAVAX (onset date unspecified). The outcome of the event was unknown. Additional information is not expected because we are not allowed to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to 19 patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the 19 patients were inadvertently vaccinated with PROQUAD (Merck) (dosage, strength, route and lot# were not reported), which had been improperly stored. There was no concomitant medication reported. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not consented to be contacted.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Confusional state, Injection site reaction, Pain, Somnolence
Clinical narrative: Redness at injection site, aching all over, confused, sleepy. Started 2-3 days afterward and continued thru 10-12-15.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Rash developed in the general area the vaccine was given.
Age: 0.92
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified patient (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On 12-OCt-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route not provided) (Lot# reported as K021929; expiration date: 28-FEB-2016, which is an invalid lot number for PROQUAD (Merck). No adverse effects were reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.04
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Clumsiness, Injection site erythema, Injection site scab, Injection site vesicles, Irritability
Clinical narrative: Pt is 12 month old female seen 10/12/15 - d/+ worsening blister that scabbed 11 days s/p varicella immun (L) thigh- pt. had systemic reaction : V x 8 12 days after immunizatoin. Irritability and clumziness. Pt temp to 97.5. (L) thigh Redness, torso papules
Age: 1.04
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Papule
Clinical narrative: Pt is 12 month old female seen 10/12/15 - d/+ worsening blister that scabbed 11 days s/p varicella immun (L) thigh- pt. had systemic reaction : V x 8 12 days after immunizatoin. Irritability and clumziness. Pt temp to 97.5. (L) thigh Redness, torso papules
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Swollen and purple arm near injection site.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Fatigue, Loss of consciousness, Pyrexia, Screaming
Clinical narrative: Fever; perpetual screaming for hours and passing out from exhaustion, then more screaming. Flailing arms and legs. No treatment was given. Dr. said we should call back if this persisted for 3 days or if his fever reached 104 degrees.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Erythema, Nausea, Pyrexia
Clinical narrative: (L) UE - increasing redness, burning, fever/chills, nausea.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Incorrect route of drug administration, Joint swelling, Joint warmth, Peripheral swelling
Clinical narrative: Patient was given MENVEO by mistake instead of MMR - MENVEO given SQ not IM.
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given MENVEO by mistake instead of MMR - MENVEO given SQ not IM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Soreness in arm where vaccinated, lasted for several days then dissipated. Symptoms returned then abated several times. Extreme fatigue, chills. Symptoms appear to be lessening, but still come and go as of today 10/17/15.  No treatment.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot#, expiration date, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of MMR II injection (lot # K016153 with expiration date 24-SEP-2016, albumin status RHA (recombinant human albumin), lot # K024038 with expiration date 26-NOV-2016, albumin status RHA, lot# L001336 with expiration date 13-JAN-2017, albumin status RHA and lot# L007577 with expiration date 05-MAR-2017 albumin status RHA: dose, frequency and route were not provided. No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (strength, dose, frequency and route of administration were not reported) lot #L008053 with an expiry date of 30-NOV-2016 and lot # K004795 with an expiry date of 30-JUL-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports 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 medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot#, expiration date, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a patient of an unknown age and gender reporting on him/herself via social media. The patient's medical history and concurrent conditions were not specified. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, vaccination site, route, lot# unspecified). Concomitant medications were not provided. The patient reported that, after being vaccinated for shingles he/she developed shingles. The outcome of the events was not reported. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 20-JUL-2015 the patient was vaccinated with dose 1 of RECOMBIVAX HB injection (lot number and expiry date not provided). On 14-AUG-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number and expiry date not provided). No adverse event reported. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot#, expiration date, dose were unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a Registered Nurse concerning to a 22 year old female patient with no drug reactions or allergies and no pertinent medical history. On 10-AUG-2015, the patient was vaccinated with the first dose of VARIVAX (Lot No. and expiration date were not provided) subcutaneously, 0.5 ml. There was no concomitant therapy. On 23-SEP-2015, when the patient was supposed to receive her second dose of VARIVAX, she found that she was pregnant. Last menstrual period was in approximately 2015 and estimate delivery date would be in approximately 2016. No treatment was given and no lab diagnostics studies were performed. The patient sought medical attention by calling to her doctor. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot#, expiration date, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reporter as healthcare worker) refers to unspecified number of patients of unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date an unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health worker referring to 9 unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot# L008271; expiration date 11-MAR-2017) dose and route of administration were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from a consumer concerning an unspecified patient (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot# not provided). The consumer reported that the patient was in process of diagnosis for autism spectrum disorder. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected, no contact details were provided.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9 (it was unknown which one of both vaccines the patient received) intramuscularly (lot#, anatomical location and frequency were unspecified). Concomitant therapies were not reported. Then, three weeks post vaccination (on an unknown date); the patient experienced a gradual onset of severe muscle pain all throughout her body. It was stated that the patient sought for medical attention visiting the physician's office, that no intervention to prevent serious criteria was necessary, that myalgia was not congenital abnormality or significant disability or incapacity or life threatening, that the patient was not hospitalized and that no PQC was involved. At the time of the report, the outcome of myalgia was unknown. The relatedness of GARDASIL or GARDASIL 9 with myalgia was not reported. This is one of several reports from the same source. Additional information is not expected since the physician did not wish further contact.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's husband referring to a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number and expiration date not provided) dose, route and anatomical location were not reported (vaccine exposure before pregnancy). No concomitant medication was provided. On an unknown date (also reported as not enough one month later), the patient was pregnant. The Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) were unknown. The pregnancy outcome was unknown at the time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. The physician read on an unspecified website that on an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9 (it was unknown which one of both vaccines the patient received) (lot#, anatomical location and frequency were unspecified) intramuscularly. Concomitant therapies were not reported. On an unknown date, the patient experienced severe muscle pain all throughout her body (myalgia). At the time of the report, the outcome of myalgia was unknown. The relatedness of GARDASIL or GARDASIL 9 with myalgia was not reported. This is one of several reports from the same source. Additional information is not expected since the physician did not wish further contact.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to one of two (case # 1508USA007834) unspecified no pregnant female patient of estimated age "about 11 or 12 years of age. The patient concurrent conditions, medical history and allergies were not provided. On an unknown date, the patient was vaccinated whether with dose of GARDASIL or GARDASIL 9, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were not provided. On an unknown date, after the vaccination, the patient vomited and sought medical attention through office visit on an unknown date. There was no treatment administered following the adverse event and the patient did not return to the office as a follow up for the adverse events. The outcome of vomiting was reported as recovered on an unknown date. The relatedness between vomiting and therapy with GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 4 month 23 days old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 29-OCT-2013, the patient was vaccinated with the 1st dose of VARIVAX (Merck) (lot # and expiry date not reported) at the mentioned age. No adverse effects were reported. Additional information has been requested.