chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Received a Flu shot at the Pharmacy and then developed Influenza, reported same to the store and they just shrugged.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pharmacy notified by patient on 11/01/2016 - complaint of pain in left arm radiating down the arm. Spoke with Pt. on 11/02/2016, 11/03/2016 and 11/09/2016. Recommended to Pt. to see MD, try Ibuprofen. To date Pt says Ibuprofen helps but pain returns. Has not seen doctor. Note: No bleeding or swelling at injection site.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Injection site swelling and redness. Patient felt "sick and had chills".
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm hurt very bad, down to fingers. It was hurting for at least 2 week after and her upper arm was getting better, but still hurt a little.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Myalgia
Clinical narrative: Received the flu shot on - 10/24/16 - a few days after the shot, the muscles in the left chest wall ache and muscles in left top back of arm and shoulder/shoulder blade area ache and burn. Pain has not subsided.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: 31/2 inch round bump.
Age: 33.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: The patient states that the vaccine was given very high on her arm. She said it hurt more than normal and she is still in pain today.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: Gushing blood bruised, elevated bump at injection site.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Several hours after receiving influenza vaccine noticed hives to bilateral inner thighs, posterior neck, bilateral axilla, buttock, bilateral wrist, posterior right knee. Was treated in ED with BENADRYL and SOLU MEDROL.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Feeling abnormal, Neck pain
Clinical narrative: Approx 15-20 min after receiving influenza vaccine pt had sharp pains upside of neck (L) which is the deltoid flu shot was pain in. Then started feeling foggy and thought she was going to pass out. The feeling came and went 3 times, whole episode lasting 5-10 min.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgraphia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. reports pain in her right shoulder (vaccine admin. Fri. 11/04) on Sat., Sun. and Mon. (11/14). She reports difficulty writing and moving her arm. She stated that she felt burning at the time of the injection.
Age: 58.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Oropharyngeal pain, Rash generalised
Clinical narrative: Patient claims 1 day after vaccine a sore throat, 2 days after vaccine a full body rash.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Reported on 11/4/16. Patient notified Employee Health and Wellness that she had a flu shot on 10/25/16 and her arm still hurts. She said she experienced pain 30-60 minutes (ache and throbbing) after shot. From day 3 to today day 10 she said her arm hurts when she moves it, she can't sleep on her left side (vaccine given (L) arm) and that it hurts in the morning and when she sleeps. Advised her to see her Health Care Provider or Urgent Care.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Edema, Pain, Redness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal pain, X-ray
Clinical narrative: Shoulder pain and soreness. Nothing helps, cold compress or heat does not help. No medications help. Constant pain and now weakness is in my skin. Loss of strength. I will never take this shot again.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Mom and Dad state patient has run fever 9 hs between 100-101 (R) since vaccine were administered on10-12-16. Temp is normal during the day- 98.6 (R). Dad has hx of allergy to nectuaria component of vaccine.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary nerve injury, Injection site injury, Pain in extremity
Clinical narrative: Patient went to hospital because Heart doctor thought the pain in his arm might be his heart but they have decided that the needle might have hit the auxiliary nerve.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pain in extremity, Sluggishness
Clinical narrative: I was given the High dose Flu shot in my left arm. Five-six days later I started feeling a little sluggish. About 5 days after that I had the flu for 2 1/2 weeks! Finally! My left arm quite hurting on 11-7-16.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Unevaluable event
Clinical narrative: See prog. notes.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Myalgia, Neck pain, Pyrexia
Clinical narrative: Patient says she has been getting muscle pain and slight fever for the past 2 weeks. She can't lift arm up sometimes and has pain up to the shoulder and neck. Injection site not swollen or infected.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus, Pyrexia
Clinical narrative: Itching, burning, and fever. She used tiger balm and BENADRYL for treatment.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Back pain, Groin pain
Clinical narrative: 10-27-16 Yellow fever vaccine. 11-2-16 thru 11-3-16 back pain, soreness, joint pain. 11-9-16 aches and pain better (at work) but now has groin pain.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthma, Condition aggravated
Clinical narrative: Given 1.Flu shot 2. Pneumonia shot at same time, which cause an asthma attack, and had to go to ER. at hospital.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 7cm area if redness, tenderness at injection site 3 days later.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Red swollen arm down halfway to elbow reported arm warn and sore to touch.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: 36 HRS after vaccine: Body aches, mild fever, sore throat, headache, fatigue, cough.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 36 HRS after vaccine: Body aches, mild fever, sore throat, headache, fatigue, cough.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The pt came in 11/10/16 and said that his arm became so sore after receiving Pneumovax 23 and Fluzone HD in his left arm 11/09/16 that he needed to go by ambulance around 5am this morning to Hospital.  The pt said he received the immunizations at 11am and by 6pm his arm became very painful. The pt said that he had used acetaminophen and iced his arm, but it did not touch the pain. The pt said that he could not lift his arm.  The pt said that the physicians there did not think it was a reaction to the immunizations, but the pt feels that it is related.  Dr. prescribed tramadol. The pt picked up the tramadol and described the event as stated above.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Patient reported a reaction to the flu shot she received last Thursday  starting the following day she had fever, nausea, increased shortness of breath, headache, and fatigue which lasted through the weekend - improved today (10/31/2016) and afebrile but still fatigued. No redness/irritation at site of shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Malaise, Muscular weakness, Myalgia
Clinical narrative: Severe pain and weakness of rt. arm (vaccine administered in rt. arm), temp to 102po, severe headache with light sensitivity, generalized muscle pain / aches, projectile vomiting. Symptoms lasted for 48 hr. Malaise lasted for additional 48 hr. Missed 2 days of work. (Health Care Professional).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Photophobia, Vomiting projectile
Clinical narrative: Severe pain and weakness of rt. arm (vaccine administered in rt. arm), temp to 102po, severe headache with light sensitivity, generalized muscle pain / aches, projectile vomiting. Symptoms lasted for 48 hr. Malaise lasted for additional 48 hr. Missed 2 days of work. (Health Care Professional).
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Oral mucosal erythema, Tonsillar ulcer
Clinical narrative: An initial erythematous patch in the area of vaccine administration which spread out all over her body and also affecting her oral mucosa with vesicles and ulcers in tonsillar pillars. Associated to subjective fever.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Insomnia, Muscular weakness, Paraesthesia
Clinical narrative: Arm sore and swollen at site of shot and difficulty sleeping for a night or 2, followed by lingering muscle weakness that persists, and occasional tingling down inside of arm. Cannot lift weight that I could lift prior to the shot.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: Arm sore and swollen at site of shot and difficulty sleeping for a night or 2, followed by lingering muscle weakness that persists, and occasional tingling down inside of arm. Cannot lift weight that I could lift prior to the shot.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: Patient reported extreme fatigue, body aches and pains.  Large red, painful area appeared on the inside and outside of the patient's right arm (same arm both immunizations were given). Patient sought medical treatment with diagnosis of cellulitis. Treated with antibiotics.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Flu Shot given 10/03/2016, in afternoon arm was hurting.  On 10/05/2016, arm now hurting into left side of neck.  Employee was advised to go to clinic for evaluation but refused to go to clinic at  9:44 AM on 10/05/2016.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Nerve injury
Clinical narrative: I felt a lot of pain about half hour after flu shot was given, but thought it was normal. It's getting worse now as the days go on. Severe pain in that spot where I got flu shot. I cannot lift my arm fully and when I sneeze, the pain goes directly to flu shot spot and it feels like someone punched me in that spot. It hurts so much.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, erythema and itching around injection site.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Pt left us message this morning that he is feeling numbness at the injection site and that he is feeling numbness in his head as well. It appeard to be unilateral, same side as the arm where flu shot was given.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt left us message this morning that he is feeling numbness at the injection site and that he is feeling numbness in his head as well. It appeard to be unilateral, same side as the arm where flu shot was given.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt left us message this morning that he is feeling numbness at the injection site and that he is feeling numbness in his head as well. It appeard to be unilateral, same side as the arm where flu shot was given.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site mass, Injection site pruritus
Clinical narrative: PATIENT HAD LARGE INFLAMMED CIRCLE ON ARM WHERE VACCINE WAS ADMINISTERED. PATIENT DESCRIBED IT AS A HARD BUMP AND ITCHY. PATIENT WENT TO EMERGENCY DEPARTMENT AND PRESCRIPTIONS FOR TREATMENT.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hypersomnia, Injection site bruising, Injection site reaction
Clinical narrative: Feeling very tired and sleeping more that usual. Very large reaction on the injection site. Large patch of bluish bruise like color on the injection site.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: After the vaccine was given, patient sat and talked to the pharmacist for a few minutes, then walked off to do some grocery shopping. About 10 minutes later, as the patient was exiting the store she fainted. Her pulse was fine, breathing was fine, she would open her eyes and make eye contact every now and then but would not speak. After a few minutes we were able to get her seated in a wheelchair. The EMS was called, they looked her over and let her leave after just a couple minutes. She was driven home by family.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt given 0.5ml at 33 months instead of 0.25ml no adverse reaction.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Back pain, Chest discomfort, Chest pain, Dyspnoea, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and influenza vaccine at unknown dose, both via an unspecified route of administration on 05Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. On 06Nov2016 she went to the pharmacist with big rash on her arm, chest tightness and pain, fever, body ache, she was like in tears and she felt very bad and felt like she got Pneumonia. Pharmacist further described adverse events as chest pain, difficulty breathing and back pain as well. The outcome of all events was unknown. A product complaint was filed. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the known adverse event profile and on the temporal relationship. The Company however considers the administration of a concomitant vaccine an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain, Pneumonia, Pyrexia, Rash, Tearfulness
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and influenza vaccine at unknown dose, both via an unspecified route of administration on 05Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. On 06Nov2016 she went to the pharmacist with big rash on her arm, chest tightness and pain, fever, body ache, she was like in tears and she felt very bad and felt like she got Pneumonia. Pharmacist further described adverse events as chest pain, difficulty breathing and back pain as well. The outcome of all events was unknown. A product complaint was filed. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the known adverse event profile and on the temporal relationship. The Company however considers the administration of a concomitant vaccine an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Significant arm swelling and redness. Arm was hot to the touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful injection. Very sore at injection site that continued. Upon inspection 48 hours later, realized that it was swollen, warm, sore & tender, along with extreme redness extending with about a 6 inch radius. Tried applying ice with no effect.  Redness and swelling diminished after 5 days.  I have never had a reaction to any kind of immunization before.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT REPORTED REDNESS AND SWELLING FROM THE SITE OF INJECTION DOWN TO THE ELBOW.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: A red band of skin formed approximately one inch wide and 3 inches across around the injection site.  The patient did not report any pain or itching.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: High fever of 104 degrees for 3-4 days, small red bumps throughout body and face. Red bumps also developed at injection site at this time.
Age: 10.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Headache, Hyperaesthesia, Hyperhidrosis, Nasopharyngitis
Clinical narrative: Cold symptoms at first, but then by next evening, chills, headache, body aches, on and off sweats, skin was sensitive to touch, congestion, stuffy head, sore throat.  Lasted through 11/14/16.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Cold symptoms at first, but then by next evening, chills, headache, body aches, on and off sweats, skin was sensitive to touch, congestion, stuffy head, sore throat.  Lasted through 11/14/16.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Per mother pt fainted about 5 hours after receiving vaccines.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient states right arm and shoulder are still sore greater than one month post injection. Flu shot was given in right deltoid.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient states he continues to experience muscle soreness and arm pain beginning the day vaccination. The pain began 1 day after immunization and continues 18 days post immunization.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Patient describes pain, heaviness, numbness, tingling sensation for over a week after vaccination. Describes inability to use that arm for a good week after vaccination. States that currently the pain, numbness and tingling are intermittent and less intense.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Discomfort, Erythema, Pyrexia, Swelling
Clinical narrative: Pt developed swelling, redness, discomfort and fever post injection.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, CSF protein increased, Fatigue, Hypoaesthesia
Clinical narrative: He received flu vaccine on 10/5/16. ~2 days after the flu vaccine, he started to feel tired and vaguely weak. He had trouble completing a bicycle ride and experienced cramps in his thighs during the ride on 10/8. He continued to feel unusually tired during the following week. On 10/17, he started noticing numbness and paresthesias in his right foot. The numbness and paresthesias progressed and continued to progress until 10/24. Symptoms have been stable since 10/24. He has numbness and paresthesias in both hands, subtle paresthesias in left arm, and numbness in lower half of body from upper abdomen level and extending distally through both lower extremities. He also feels slight weakness in his hands. He has trouble typing because of the numbness in his hands and fingers. He has to be careful walking because of the numbness in his feet. He was treated with intravenous immunoglobulin (IVIG) 2 grams/kg administered over 3 days from 10/19-10/21/2016.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Muscle spasms, Muscular weakness, Paraesthesia
Clinical narrative: He received flu vaccine on 10/5/16. ~2 days after the flu vaccine, he started to feel tired and vaguely weak. He had trouble completing a bicycle ride and experienced cramps in his thighs during the ride on 10/8. He continued to feel unusually tired during the following week. On 10/17, he started noticing numbness and paresthesias in his right foot. The numbness and paresthesias progressed and continued to progress until 10/24. Symptoms have been stable since 10/24. He has numbness and paresthesias in both hands, subtle paresthesias in left arm, and numbness in lower half of body from upper abdomen level and extending distally through both lower extremities. He also feels slight weakness in his hands. He has trouble typing because of the numbness in his hands and fingers. He has to be careful walking because of the numbness in his feet. He was treated with intravenous immunoglobulin (IVIG) 2 grams/kg administered over 3 days from 10/19-10/21/2016.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Chills, Dizziness postural, Pain, Pyrexia
Clinical narrative: 101 fever, chills, body/bone aches, dizziness when standing for the night and day following the shot.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash, getting progressively worse. Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site inflammation, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Pt came in with a 3inch in diamter inflamed site with slight welping. Pt also stated the site was slightly itchy and grew in size since sat 11/12/16 till today 11/14/16. (injection was administered 11/8/16). pt was recommended to use an ice pack, liquid benadryl, and APAP/NSAID.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Extreme pain, redness and swelling of arm down almost to the wrist. Called Doctor who recommended ice and pain reliever. Said if a temperature developed to go to urgent care. Still some swelling and discomfort 3 days later.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Asthenia, Cough, Dyspnoea, Fatigue
Clinical narrative: I went into my Drs. Office on October 8th for a routine Physical that I had been avoiding for a while. After my physical, I was offered a flu shot and I agreed to take because of my four year old son. After a couple of days, around Tuesday, I begin to feel a bit under the weather. I was informed that this may occur, so I begin to treat myself with over the counter medication. I begin to feel a little better for about a week or so but still had some effects of feeling under the weather. On October 20, I traveled. During my departure flight, I specifically remember having severe heart palpitations that came out of nowhere as well as severe stomach cramps. Because I was in such a tight environment, I sat there helplessly not knowing what was going on with my body. After getting a couple of glasses of water from flight attendant, I would eventually take a Fish oil pill that I had in my purse and it did provide me w/ some relief. The palpitations continued throughout my entire trip, and they would appear off and on. It was very unusual. I would get relief by continuing w/ the Fish oil pills. That Sunday night, while hanging on beach with friends is when I started to notice the shortness of breath. By the time I arrived home on Monday, October 24th, I begin to feel under the weather again. By that Tuesday, I was begin feeling as if I had the flu all over again. This time I have the cough from hell and the body aches like never before. I treated over the counter for about a week. When I couldn't take the shortness of breath, the achiness, and weakness, and feeling tired all of the time, I eventually called Dr. who told me to come into the office. After discussing symptoms he (Dr.) sent me to Hospital for several test that were all negative. I have gone to Drs. office about 3 times, including trip to ER. I still have same symptoms not to mention swelling in my left arm where injection was given. I arm continues to swell and no one (Dr. ) knows why and have not treated me because they don't know what this is. Please help. I am a mom to a year old son, a grad student, and a full time employee. I cannot afford to be sick for over a month. Please help me.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Injection site swelling, Laboratory test normal, Malaise, Pain
Clinical narrative: I went into my Drs. Office on October 8th for a routine Physical that I had been avoiding for a while. After my physical, I was offered a flu shot and I agreed to take because of my four year old son. After a couple of days, around Tuesday, I begin to feel a bit under the weather. I was informed that this may occur, so I begin to treat myself with over the counter medication. I begin to feel a little better for about a week or so but still had some effects of feeling under the weather. On October 20, I traveled. During my departure flight, I specifically remember having severe heart palpitations that came out of nowhere as well as severe stomach cramps. Because I was in such a tight environment, I sat there helplessly not knowing what was going on with my body. After getting a couple of glasses of water from flight attendant, I would eventually take a Fish oil pill that I had in my purse and it did provide me w/ some relief. The palpitations continued throughout my entire trip, and they would appear off and on. It was very unusual. I would get relief by continuing w/ the Fish oil pills. That Sunday night, while hanging on beach with friends is when I started to notice the shortness of breath. By the time I arrived home on Monday, October 24th, I begin to feel under the weather again. By that Tuesday, I was begin feeling as if I had the flu all over again. This time I have the cough from hell and the body aches like never before. I treated over the counter for about a week. When I couldn't take the shortness of breath, the achiness, and weakness, and feeling tired all of the time, I eventually called Dr. who told me to come into the office. After discussing symptoms he (Dr.) sent me to Hospital for several test that were all negative. I have gone to Drs. office about 3 times, including trip to ER. I still have same symptoms not to mention swelling in my left arm where injection was given. I arm continues to swell and no one (Dr. ) knows why and have not treated me because they don't know what this is. Please help. I am a mom to a year old son, a grad student, and a full time employee. I cannot afford to be sick for over a month. Please help me.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: I went into my Drs. Office on October 8th for a routine Physical that I had been avoiding for a while. After my physical, I was offered a flu shot and I agreed to take because of my four year old son. After a couple of days, around Tuesday, I begin to feel a bit under the weather. I was informed that this may occur, so I begin to treat myself with over the counter medication. I begin to feel a little better for about a week or so but still had some effects of feeling under the weather. On October 20, I traveled. During my departure flight, I specifically remember having severe heart palpitations that came out of nowhere as well as severe stomach cramps. Because I was in such a tight environment, I sat there helplessly not knowing what was going on with my body. After getting a couple of glasses of water from flight attendant, I would eventually take a Fish oil pill that I had in my purse and it did provide me w/ some relief. The palpitations continued throughout my entire trip, and they would appear off and on. It was very unusual. I would get relief by continuing w/ the Fish oil pills. That Sunday night, while hanging on beach with friends is when I started to notice the shortness of breath. By the time I arrived home on Monday, October 24th, I begin to feel under the weather again. By that Tuesday, I was begin feeling as if I had the flu all over again. This time I have the cough from hell and the body aches like never before. I treated over the counter for about a week. When I couldn't take the shortness of breath, the achiness, and weakness, and feeling tired all of the time, I eventually called Dr. who told me to come into the office. After discussing symptoms he (Dr.) sent me to Hospital for several test that were all negative. I have gone to Drs. office about 3 times, including trip to ER. I still have same symptoms not to mention swelling in my left arm where injection was given. I arm continues to swell and no one (Dr. ) knows why and have not treated me because they don't know what this is. Please help. I am a mom to a year old son, a grad student, and a full time employee. I cannot afford to be sick for over a month. Please help me.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Aphasia, Autism, Speech disorder developmental
Clinical narrative: Soon after MMR vaccine he lost all ability to talk. Could not make noises. Soon started showing signs of austism. Diagnosed with autism at 18 months. Before vaccine he showed no signs and could talk in three word sentences.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Diplopia, Guillain-Barre syndrome, Hypoaesthesia, Influenza like illness
Clinical narrative: GBS (Miller-Fisher Variant). Flu like symptoms, numbness in legs, up to knee, ache, night sweats, double vision.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture, Miller Fisher syndrome, Night sweats, Nuclear magnetic resonance imaging, Pain
Clinical narrative: GBS (Miller-Fisher Variant). Flu like symptoms, numbness in legs, up to knee, ache, night sweats, double vision.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Stool analysis, Urine analysis
Clinical narrative: GBS (Miller-Fisher Variant). Flu like symptoms, numbness in legs, up to knee, ache, night sweats, double vision.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fall, Laceration, Suture insertion
Clinical narrative: On 10/18/16, patient got dizzy then fell. She hit a brick wall and required stitches near her eye. She reports weakness after getting flu shot too.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Injection site reaction, Scratch
Clinical narrative: 10/6/16 At 3:37PM, cleaned left deltoid with alcohol and gauze, injection syringe needle into left deltoid after feeling 2 fingerbreadths below acromial process. Pt. cooperative. Patient moved away from needle stick pronto on insertion injection of Influenza vaccine causing needle scratch on left deltoid area approximately 11/2 inch. Cleaned with alcohol and gauze, applied 3 bandaids.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Hives and itching injection site occurred on Sun/Mon (vaccine given Fri).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Cannot move arm as far as she could before - recommended ibuprofen and physician.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: In gluteal. Felt like some one "punched" me in the hip for about 5 days. Lot 56207 AFLURIA.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: "Shaking all over. Better at day 2, but still shaking a little".
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness and induration (L) lateral and anterior thigh at site of PROQUAD and Influenza administration. No pain/tenderness/nor itching noted. Advised oral ibuprofen as needed. Area was warm to touch.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out roughly 2 minutes after vaccine. EMS was called and checked him out. He was advised not to drive and have someone pick him up.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Approximately 20 minutes after vaccine administration patient indicated swelling and "tingling" on right cheek.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore left arm - cannot raise left arm since flu shot administered and continue for 2 weeks. Pt. states that pharmacist administered shot into shoulder instead of Deltoid.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Red, hot under arm where vaccine was given. Urged patient to seek medical attention ASAP.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: Nausea, aches, flu-like symptoms, fatigue for 3 days.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling in arm -Decreased mobility -Level 5 discomfort.
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Weight bearing difficulty
Clinical narrative: Pt called today and informed pharmacist that she's been having pain in one of her legs whenever she puts pressure on it or perform heavy duty use of that particular leg. She noticed the pain/weakness the day after vaccine administration.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Dyspnoea, Flushing
Clinical narrative: Flushing, shortness of breath, back pain after flu and pneumonia shots approximately 503 pm. EPIPEN given at 5:06. Breathing improved. Paramedic arrived at 5:15 pm.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm started swelling day after injection of 11/09/16. Swelling has moved to elbow and it itches like crazy. Taking BENADRYL has been helping.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site bruise, Administration site swelling, Fatigue
Clinical narrative: Pt reported a day's worth of fatigue, large swelling, bruising on the site of administration.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Arm with 7x8 cm circumferential erythema with minimal swelling, minimal tenderness child without fever.
Age: 70.0
Sex: U
Vaccine: FLU3, UNK
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Date: 10/21/16. Symptom: Soreness at site, muscle ache, prickly - tingling in thumb, index, middle, ring fingers, numbness also. 10/21/16 till 11/8 and counting - no improvement!
Age: 70.0
Sex: U
Vaccine: FLU3, UNK
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Date: 10/21/16. Symptom: Soreness at site, muscle ache, prickly - tingling in thumb, index, middle, ring fingers, numbness also. 10/21/16 till 11/8 and counting - no improvement!
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse via a company representative referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions were not reported. On an unknown date, the patient was administered a second dose of PNEUMOVAX 23 (strength, dose, lot# expiration date and route unknown) 2-3 years after the first dose (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant concerning unspecified patients of unknown age gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, an unspecified number of patients were administered improperly stored doses of GARDASIL 9 (lot# and expiration date, strength, dose, frequency and route were not 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 an office manager referring to an unspecified number of patients. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # M017983, expiration date 30-MAY-2018) which was improperly stored at 48.9 F for 48 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an officer manager referring to an unspecified number of patients. On unknown dates the patients were vaccinated with M-M-R II (lot # M015931, expiration date 30-MAR-2018) which was improperly stored at 48.9 F for 48 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since from 25-FEB-2016 to 01-MAR-2016, these patients were vaccinated with improperly stored doses of M-M-R II (lot# L024266 and expiry date 01-JUL-2017, lot# K005110 and expiry date 04-APR-2016) (strength, dosing details, anatomical location and route were unknown). These vaccine lots underwent temperature excursion from 25-FEB-2016 to 01-MAR-2016 and were exposed to the temperature of 10.3 degree Celsius for 108 hours. No adverse effects were reported. No product quality complaint was involved. 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 medical assistant refers to an unspecified number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since from 25-FEB-2016 to 01-MAR-2016, these patients were vaccinated with improperly stored doses of ROTATEQ (lot#L037921 and expiry date 31-MAY-2017, lot#L020859 and expiry date 19-JAN-2017, lot#L026740 and expiry date 16-APR-2017) (strength, dosing details, anatomical location and route were unknown). These vaccine lots underwent temperature excursion from 25-FEB-2016 to 01-MAR-2016 and were exposed to the temperature of 10.3 degree Celsius for 108 hours. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Reading disorder
Clinical narrative: This spontaneous report as received from a patient's daughter and refers to a 62 year old female patient. The patient's concurrent conditions included drug reactions or allergies to penicillin. On 25-OCT-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included NEURONTIN, CYMBALTA and ZEGERID. On 25-OCT-2016 within 4 to 5 hours after receiving the vaccination, the patient experienced headaches. On 26-OCT-2016 (the following day), the patient felt fatigued and had difficulty reading. The patient contacted the pharmacy where she received the ZOSTAVAX vaccine, but was not treated for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The relatedness between the events and ZOSTAVAX was not reported. 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 pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date, dose were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as not consent was given for further contact.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Headache, Nausea, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. Previously administered products included BEXSERO with an associated reaction of headache (refer case US2016163459) and BEXSERO with an associated reaction of nausea (refer case US2016163459). On 2nd November 2016, the patient received the 2nd dose of BEXSERO. In November 2016, less than a week after receiving BEXSERO, the patient experienced headache, vomiting and abdominal pain. On an unknown date, the outcome of the headache, vomiting and abdominal pain were unknown. It was unknown if the reporter considered the headache, vomiting and abdominal pain to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in left arm. No further information was provided.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO. On 3rd October 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were unknown. It was unknown if the reporter considered the headache and nausea to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in right arm. No further information was provided. This case has been linked with case US2016GSK166854, reported the same reporter for the same patient.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 31-DEC-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. 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: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. 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: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 14-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. 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: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 and 8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Peripheral swelling, Phlebitis, Skin warm
Clinical narrative: Patient received PNEUMOVAX 23 in (R) deltoid on 11/7 pt had onset of redness down to wrist, swelling, warm to the touch and tenderness/fatigue in (R) arm-went to walk in clinic diagnosed w/phlebitis.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient received PNEUMOVAX 23 in (R) deltoid on 11/7 pt had onset of redness down to wrist, swelling, warm to the touch and tenderness/fatigue in (R) arm-went to walk in clinic diagnosed w/phlebitis.