chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about November 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On or about November 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On an unknown date in 2015, the patient was treated by her healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On or about 2014, the patient was treated by a physician's assistant for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about July 2015, a healthcare provider administered the ZOSTAVAX to the patient. On or about 30-DEC-2016, the patient was treated by the physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: SHOULDER PAIN, ARM PAIN AT INJECTION SITE.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fatigue, Loss of personal independence in daily activities, Somnolence
Clinical narrative: Tired and went to bed very early on night of vaccination; awoke after full night of sleep feeling groggy; woozy upon standing; poor balance; light-headed; felt tipsy, as if I had had too much to drink (no alcohol ingested); developed vertigo; when I closed my eyes, the room was spinning; canceled my volunteer work; slept 4 hours; at present, about 24 hours post vaccine, I seem to be returning to normal.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Tired and went to bed very early on night of vaccination; awoke after full night of sleep feeling groggy; woozy upon standing; poor balance; light-headed; felt tipsy, as if I had had too much to drink (no alcohol ingested); developed vertigo; when I closed my eyes, the room was spinning; canceled my volunteer work; slept 4 hours; at present, about 24 hours post vaccine, I seem to be returning to normal.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site, X-ray
Clinical narrative: Vaccine was given in the left joint, not the left muscle. Caused severe pain, unable to lift left arm, and am still unable to lift left arm and am still in severe pain.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient received a high dose flu shot at pharmacy 10/23/18. She had pain in her arm at the injection site that began about 6 hours after the vaccine and has persisted (until present - 11/5/18). She has a feeling of weakness and mild numbness and tingling in the arm, but a normal physical examination.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient came to pharmacy today 11/5/18, stating that they had a reaction after getting the flu shot. Patient said arm was fine until a couple days after getting the shot, then an "achy" feeling started and moved up the arm to the shoulder. Pain is not constant; it comes and goes. Patient could not report any specific thing that seems to irritate it.  Patient reports no swelling, and specified, that the feeling is not necessarily pain, but more "achy."  Patient reports no issues with movement or range of motion, but wanted to let us know and ask what they should do because it is not going away. We are contacting the physician to let them know, and told patient to see physician if pain continues. We will contact patient again in the next day or two to follow up and see if they are still sore.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Dizziness, Pyrexia, Urticaria, Vision blurred
Clinical narrative: 102.8 fever for 3 days, hives for 14 days, pain in abdomen for 5 days, as of 11/5 blurred vision and dizziness treatment included MEDROL DOSEPAK, followed by prednisone injection and oral prednisone.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Myalgia
Clinical narrative: Bad stomach cramps, chills, muscle ache and diarrhea.
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: PATIENT GIVEN VACCINE IN RIGHT THIGH. APPROXIMATELY 10 MINUTES AFTER PARENT NOTED THAT HIVES WERE APPEARING ON RIGHT SIDE OF FACE. IMMEDIATELY GRABBED A NURSE AND PROVIDER SINCE CHILD WAS NOT HAVING ANY DIFFICULTY BREATHING. UPON FURTHER INSPECTION; HIVES WERE NOTED ON LEFT SHOULD AND LEFT THIGH AS WELL. PROVIDER PRESCRIBED BENADRYL TO ASSIST WITH HIVES.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced swelling, irritation, itching and redness at the injection site the day of the vaccine. The following day the redness and swelling had expanded and eventually would span the length of her arm from her shoulder to her elbow. These symptoms lasted approximately 2 weeks.  She self-treated with calamine lotion and did not seek medical attention.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after vaccination.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan, X-ray
Clinical narrative: Swelling and redness with pain at the injection site lasting over 1 month.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: I went into the doctor for a routine skin check and asked where in the facility I could get a flu shot. I had a six week baby at the time and a toddler and needed to get a flu shot during my visit to the facility. The dermatologist's office said that they could give me the shot. After my skin test, the nurse prepared to give me the shot in my upper right arm. She stuck the needle in, administered some of the vaccine, and then removed the needle. She then reinserted the needle and put the rest of the vaccine in my arm. She covered it with a Band-Aid. Immediately after the shot, I had discomfort, soreness and limited range of motion in my arm but - having had a flu shot in the past - thought that this was normal and ignored it. The pain persisted and got progressively worse over the course of two weeks. Finally, the pain got so bad on day 10 and 11 that I contacted the doctor's office and let them know and asked to be seen. I cannot lift my right arm higher than shoulder height and if my arm is bent, I can't lift it at all. This means that I cannot pick up my infant daughter (now 8 weeks old) or my toddler, or do normal things with my arm. This is my dominant arm and it has made day to day activities very difficult and painful. The pain is greatest when I am trying to move my arm - but there is also dull pain when it is at rest. The pain kept me up several nights ago. The pain is localized in the location of where the shot was administered. It feels like muscle damage. There is no external signs of infection.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: I went into the doctor for a routine skin check and asked where in the facility I could get a flu shot. I had a six week baby at the time and a toddler and needed to get a flu shot during my visit to the facility. The dermatologist's office said that they could give me the shot. After my skin test, the nurse prepared to give me the shot in my upper right arm. She stuck the needle in, administered some of the vaccine, and then removed the needle. She then reinserted the needle and put the rest of the vaccine in my arm. She covered it with a Band-Aid. Immediately after the shot, I had discomfort, soreness and limited range of motion in my arm but - having had a flu shot in the past - thought that this was normal and ignored it. The pain persisted and got progressively worse over the course of two weeks. Finally, the pain got so bad on day 10 and 11 that I contacted the doctor's office and let them know and asked to be seen. I cannot lift my right arm higher than shoulder height and if my arm is bent, I can't lift it at all. This means that I cannot pick up my infant daughter (now 8 weeks old) or my toddler, or do normal things with my arm. This is my dominant arm and it has made day to day activities very difficult and painful. The pain is greatest when I am trying to move my arm - but there is also dull pain when it is at rest. The pain kept me up several nights ago. The pain is localized in the location of where the shot was administered. It feels like muscle damage. There is no external signs of infection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Dysuria, Erythema
Clinical narrative: First was weakness, dizzy, exhausted, I thought I had UTI because I needed to urinate, it was a little painful, then needed to again within an hour. That went away. My arm swelled, got hard and red and painful, then the cold/bronchial symptoms started. Coughing constantly, (painful) headache, terrible conjestion, hard phlegm in my throat that I cannot clear, some fever. Today is November 5. I went to the doctor  esterday, got a bunch of prescriptions and some over the counter. It is still going on!
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Induration, Nasopharyngitis, Pain in extremity
Clinical narrative: First was weakness, dizzy, exhausted, I thought I had UTI because I needed to urinate, it was a little painful, then needed to again within an hour. That went away. My arm swelled, got hard and red and painful, then the cold/bronchial symptoms started. Coughing constantly, (painful) headache, terrible conjestion, hard phlegm in my throat that I cannot clear, some fever. Today is November 5. I went to the doctor  esterday, got a bunch of prescriptions and some over the counter. It is still going on!
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Productive cough, Pyrexia, Respiratory tract congestion
Clinical narrative: First was weakness, dizzy, exhausted, I thought I had UTI because I needed to urinate, it was a little painful, then needed to again within an hour. That went away. My arm swelled, got hard and red and painful, then the cold/bronchial symptoms started. Coughing constantly, (painful) headache, terrible conjestion, hard phlegm in my throat that I cannot clear, some fever. Today is November 5. I went to the doctor  esterday, got a bunch of prescriptions and some over the counter. It is still going on!
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Erythema, Pain, Peripheral swelling
Clinical narrative: PATIENT REPORTS WAKING AT 3AM AFTER GETTING THE SHOT WITH EXTREME JOINT PAIN, FULL BODY ACHE AND RED SWOLLEN ARM.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Myalgia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was sore the day of vaccine. The next day (11/4/18) the patient's arm became very red, hot, swollen, painful to the touch and muscle was very sore. Patient is feeling better on 11/5/18  but it is not resolved. Arm is still sore and it is inhibiting him from going climbing with his family.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: On Nov. 1, the day after the vaccine, I noticed a 1" x 2" raised red wheal that was hot, hard and very sore. I contacted the doctor on Nov 2, and they advised warm moist heat 20 minutes, 4 times a day. They were going to add prednisone, but I was already on prednisone, so we added BENADRYL. Today, November 5, the injection site is pink, no heat, not raised, but still sore. The doctor did offer to see me on Friday Nov 2, but I wanted to try the heat and BENADRYL first and see them only if it didn't improve (or if it worsened).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Gait disturbance, Induration, Irritability, Pain
Clinical narrative: Mom called triage line 11/5/18 @ 1546. Mom reported on 11/1/8 redness and hard spot noted to thigh. Daughter C/O pain and refused to walk on leg. Daughter had emesis x 1. Daughter seemed fussier than usual. Mom considered bringing in child for assessment, but did not due to her schedule. Redness, hard spot, pain no longer present.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Mom called triage line 11/5/18 @ 1546. Mom reported on 11/1/8 redness and hard spot noted to thigh. Daughter C/O pain and refused to walk on leg. Daughter had emesis x 1. Daughter seemed fussier than usual. Mom considered bringing in child for assessment, but did not due to her schedule. Redness, hard spot, pain no longer present.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pallor, Rash, Urticaria
Clinical narrative: Rash and Hives mostly on the injected arm and other parts of body. Day 6 rash continues to bloom and hives now on buttocks, Using Topical BENADRYL. She went to Urgent care, Documented erythematous, blanching raised wheals to bilateral axilla left more than right lesions noted below both breasts and anterior thighs. Declined Prescription Prednisone OTC antihistamines.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cytogenetic analysis normal, Dyskinesia, Electroencephalogram abnormal, Myoclonic epilepsy, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Patient was given 4 months vaccinations at the pediatricians office and later went down for a nap. When the patient woke up she presented with oscillating rhythmic jerking. Parents took patient to Hospital, where they ran test and later said she had a myoclonic seizure disorder. They prescribed vitamins and seizure medications (KEPPRA and ONFI). After her one week hospital stay patient came home where her jerks got worse and presented more like seizures. Patient was weaned off of seizure medications and when she was 9 months old she had a 5 plus minute seizure. Patient was taken to the hospital where more tests were run and she was put back on KEPPRA. Once back at home seizures looked more like the jerks from before and Patient started therapy. Patient was then taken to another Hospital for a second opinion. At hospital the neurologist stated that she did not have a seizure disorder after looking at an EEG their hospital performed. The neurologist also did an MRI that stated that her ventricles appeared bright asking the parents if mother had a normal pregnancy, if patient lost oxygen at any point, or if patient had a cardiac event. Mother had a normal pregnancy and the patient did not lose oxygen or have a cardiac event to the parents or doctors knowledge.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Patient was given 4 months vaccinations at the pediatricians office and later went down for a nap. When the patient woke up she presented with oscillating rhythmic jerking. Parents took patient to Hospital, where they ran test and later said she had a myoclonic seizure disorder. They prescribed vitamins and seizure medications (KEPPRA and ONFI). After her one week hospital stay patient came home where her jerks got worse and presented more like seizures. Patient was weaned off of seizure medications and when she was 9 months old she had a 5 plus minute seizure. Patient was taken to the hospital where more tests were run and she was put back on KEPPRA. Once back at home seizures looked more like the jerks from before and Patient started therapy. Patient was then taken to another Hospital for a second opinion. At hospital the neurologist stated that she did not have a seizure disorder after looking at an EEG their hospital performed. The neurologist also did an MRI that stated that her ventricles appeared bright asking the parents if mother had a normal pregnancy, if patient lost oxygen at any point, or if patient had a cardiac event. Mother had a normal pregnancy and the patient did not lose oxygen or have a cardiac event to the parents or doctors knowledge.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: Patient complaining of joint pain - knees, elbows, lower back, hips.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient stated she noticed arm getting red and area spreading from injection sign extending to the ante cubital area. Patient reports no soreness or itching, just redness.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haemorrhage, Pain in extremity
Clinical narrative: Pt reported that after the shot she was bleeding quite a bit and had a bruise where she received the shot. 11/5 she called to report that she still has a small bruise where the injection was given and pain in the arm when she touches it or lays on it. She does not have any problem moving her arm up or down or behind her back its only tender when touched.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bed rest, Erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt came in 10/30 for imz listed above - administered around 130pm by relief pharmacist - both in same arm - RPh did tell me they are given at least 1in apart but not noted exactly in consent form - pt said her arm started hurting that night and when she woke in the morning she had to stay in bed and miss work the next two days because she was feeling so badly. She did not call the pharmacy with this concern until Friday, Nov 2 then came in on Saturday, Nov 3 to show the pharmacist working her very red arm. Pt was instructed by RPh to use ice packs to help with site swelling, ibuprofen for discomfort and inflammation and also possibly BENADRYL. As the pharmacy manager today, Monday, Nov 5, I called to follow up with pt to see how she was doing. She did not see her Dr regarding the concern but had two family members that were nurses and they looked at it and said it was a result of both vaccines being given in the same arm.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Feeling abnormal, Head injury, Headache
Clinical narrative: BEFORE BE GIVEN FLUCELVAX, PATIENT STATED SHE IS NERVOUS ABOUT NEEDLES. PATIENT WAS ASKED IF SHE HAS GIVEN FLU SHOT IN THE PAST. SHE STATED YES; WITH NO PROBLEM. AFTER GETTING THE SHOT, PATIENT CAME OVER THE COUNTER TO SIGN PATIENT RELEASE. SHE STATED SHE DID NOT FEEL GOOD THEN PATIENT FELL DOWN. HIT HER HEAD ON THE COUNTER. SHE WAS LYING ON THE FLOOR. SHE HAD HER EYES OPEN; TALKED TO US. DID NOT WANT US TO CALL 911. AFTER FEW MINUTES, SHE SEEMED NOT TO FEEL WELL. ONE OF THE WITNESSES CALLED 911 WHILE WE TENDING TO PATIENT. SHE STATED SHE FEELING OK THEN STATED SHE HAVING LITTLE HEADACHE. SHE'S TALKED TO US TILL EMT ARRIVED. PATIENT WAS TAKEN TO HOSPITAL FOR FURTHER EXAMINATION BY AMBULANCE.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen right arm, erythema, patient stated feels warm (she had me touch her arm & I did not note any fever/heat). States it was painful especially the first night and reported day 3 at which time it was tolerable.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Guest complains of injection side pain and soreness months after the injection, says is having pain in her arm and can't do daily tasks without residual pain in left arm. Guest received shot on 9/6/18 and reported to pharmacy on 11/3/18. Pharmacist spoke with guest on 11/5/18, guest had said she had seen her primary care doctor and was told to take anti-inflammatory medications and pain still hasn't resolved 2 months after shot. Advised patient to reach out to get medical help for pain, and that we will conduct research regarding possible incident. Guest says "was reading online about someone who received flu-shot too high in the arm and had some injury and inflammation in arm, don't know if the pain and symptoms are in my head, but the pain is worse". Will be escalating to do further research per pharmacy protocol.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: At first the Injection site was swollen, red and painful to the touch; after that the pain radiated up to the Left Shoulder across the neck and over to Right Shoulder.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Pt came in complaining of a warm and red arm. I told her to put a cold compress on it and report to a dr if it gets worse.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Injection site discomfort, Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: ARNP Note 10/16/18 1100 48 yo male Clinical Technologist presented to EH with c/o left sore deltoid x 10 days. Reported receiving yearly flu shot on 10/5/18 in EH and denied problems with administration. However a couple of hours later developed an achy pain at injection site with now resolved tingling in left hand 4th and 5th digits. Endorsed occasional sharp pain from deltoid to elbow but overall the pain is in the left deltoid. Today pain 3/10 but increases 5/10 with sharp pain. Will have increased discomfort to area when lying on left side or leaning against sofa after 30 min. This past weekend thought the pain was less but then it seemed  to return to 3/10 yesterday. No prior LUE injuries. Taking ibuprofen 200 mg po q 4-6 hours prn. No f/c. No erythema or warmth to site; no ecchymosis. No HA. No numbness, tingling or extremity weakness. O. In NAD; MSK: Neck: No midpoint tenderness; FROM w/o pain elicited Shoulder: No SC or AC joint tenderness; no bony deformity. No erythema, edema or warmth to deltoid; supple FROM with only slight discomfort elicited in left deltoid with maneuvers. 5/5 strength with sensation intact. Sensation test to lateral arms intact for axillary nerve 2++ tricep/bicep DTRs. Strong bilateral radial and ulnar pulses with cap refill < 3 sec Back: No spinous process tenderness; no step offs; no paravertebral tenderness. A. Left Deltoid Pain No overt pathology. Most likely deltoid soreness r/t trauma of injection needle into the muscle, leading to muscle contusion P. Increase ibuprofen to 400-600 mg po q 8 hours; take with food Moist warm compresses to area 10-20 min on; 30 min off repeat qid/prn Return in 2 weeks if no improvement or sooner if pain increases, decrease extremity function, numbness, tingling. Verbalized understanding ARNP. 10/22/18-- c/o shoulder pain persisting over the weekend, has appt with PCP, enc f/u Seen by Dr. on 10/23/2018 and diagnosed with bursitis. per pt "I saw my primary care provider last week and he has diagnosed me with acute bursitis due to improper placement of the vaccination. He wanted me to make sure that your department had filed a VAERS report ".
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: ARNP Note 10/16/18 1100 48 yo male Clinical Technologist presented to EH with c/o left sore deltoid x 10 days. Reported receiving yearly flu shot on 10/5/18 in EH and denied problems with administration. However a couple of hours later developed an achy pain at injection site with now resolved tingling in left hand 4th and 5th digits. Endorsed occasional sharp pain from deltoid to elbow but overall the pain is in the left deltoid. Today pain 3/10 but increases 5/10 with sharp pain. Will have increased discomfort to area when lying on left side or leaning against sofa after 30 min. This past weekend thought the pain was less but then it seemed  to return to 3/10 yesterday. No prior LUE injuries. Taking ibuprofen 200 mg po q 4-6 hours prn. No f/c. No erythema or warmth to site; no ecchymosis. No HA. No numbness, tingling or extremity weakness. O. In NAD; MSK: Neck: No midpoint tenderness; FROM w/o pain elicited Shoulder: No SC or AC joint tenderness; no bony deformity. No erythema, edema or warmth to deltoid; supple FROM with only slight discomfort elicited in left deltoid with maneuvers. 5/5 strength with sensation intact. Sensation test to lateral arms intact for axillary nerve 2++ tricep/bicep DTRs. Strong bilateral radial and ulnar pulses with cap refill < 3 sec Back: No spinous process tenderness; no step offs; no paravertebral tenderness. A. Left Deltoid Pain No overt pathology. Most likely deltoid soreness r/t trauma of injection needle into the muscle, leading to muscle contusion P. Increase ibuprofen to 400-600 mg po q 8 hours; take with food Moist warm compresses to area 10-20 min on; 30 min off repeat qid/prn Return in 2 weeks if no improvement or sooner if pain increases, decrease extremity function, numbness, tingling. Verbalized understanding ARNP. 10/22/18-- c/o shoulder pain persisting over the weekend, has appt with PCP, enc f/u Seen by Dr. on 10/23/2018 and diagnosed with bursitis. per pt "I saw my primary care provider last week and he has diagnosed me with acute bursitis due to improper placement of the vaccination. He wanted me to make sure that your department had filed a VAERS report ".
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Pt reports not feeling well on Tuesday after shot, on Wednesday pt experienced swelling and rash on arm, Sunday the reaction went away, small swelling and rash on lower arm below bicep today, pt took aspirin, pt took ibuprofen, pt did have fever tuesday, will go next wednesay to Dr to Dr.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stating that her left shoulder was very sore. Patient could not lift her arm.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Dry eye, Fatigue, Rash
Clinical narrative: Tiredness, dry eyes, developed a rash on torso.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin burning sensation, Swelling
Clinical narrative: Pt described burning, itchy, red puffy skin. Swollen about 3 in in diameter. Symptoms still present on 11-05-18.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Inflammation at injection site, soreness, redness, painful.
Age: 72.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received the 2nd dose of HAVRIX 1 month after first dose instead of 6 months later. Spoke with the manufacturer and the protocol is to recommend the patient get the 2nd dose again but six months later. Spoke with patient and pt understands.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: After injection, bleeding, then immediate swelling at injection site. Applied cold compress at injection site for 15 minutes. Patient complained about itching at site and as time went on, complained about itching on face, chest and other arm. Gave 50mg of oral BENADRYL after trial of cold compress without complete resolve. After about 20 minutes after BENADRYL dose, patient swelling decreased and itching decreased but not fully resolved.
Age: 1.33
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain, Pruritus, Rash generalised, Rash vesicular
Clinical narrative: PT with full body vesicular rash with scabbing and erythema, itching, pain and swelling with open sores from itching. PT rash started within 48 hours of 15 month vaccinations. Per mother PT on normal CDC schedule as far as she knows so she believes PT received Hep B, HIB, PCV, IPV, MMR, Varicela, DTAP and possibly hep A. Per mother will get complete list from pediatrician.
Age: 1.33
Sex: M
Vaccine: UNK
Symptoms: Scab, Swelling, Ulcer
Clinical narrative: PT with full body vesicular rash with scabbing and erythema, itching, pain and swelling with open sores from itching. PT rash started within 48 hours of 15 month vaccinations. Per mother PT on normal CDC schedule as far as she knows so she believes PT received Hep B, HIB, PCV, IPV, MMR, Varicela, DTAP and possibly hep A. Per mother will get complete list from pediatrician.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Flu Shot.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Full blood count normal, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: First off the injection was not given in my deltoid muscle it was given in my bicep. Within 15 minutes of getting the vaccine I had gotten a white raised hive around the injection site that became very itchy and I began to get a red rash around the hive that was irregular. It quickly became bigger and became raised over the next few hours. It was extremely hot to the touch and painful, unlike any flu vaccine I've ever received. The next two days it continuously got bigger and more red wrapping around my arm. I went to urgent care on Sunday and it measured 9cm by 12cm. It was still very hot to the touch and bright red, itchy and painful. I was having shooting pain down my arm, numbness in my hand and fingers and itching in my hand and fingers. On Saturday night I had gotten a rash on the right side of my face and neck. From Friday night on I kept getting dizzy and light headed feeling like I was going to pass out. I have never had a reaction from any vaccines previously.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Injection site warmth, Pain
Clinical narrative: First off the injection was not given in my deltoid muscle it was given in my bicep. Within 15 minutes of getting the vaccine I had gotten a white raised hive around the injection site that became very itchy and I began to get a red rash around the hive that was irregular. It quickly became bigger and became raised over the next few hours. It was extremely hot to the touch and painful, unlike any flu vaccine I've ever received. The next two days it continuously got bigger and more red wrapping around my arm. I went to urgent care on Sunday and it measured 9cm by 12cm. It was still very hot to the touch and bright red, itchy and painful. I was having shooting pain down my arm, numbness in my hand and fingers and itching in my hand and fingers. On Saturday night I had gotten a rash on the right side of my face and neck. From Friday night on I kept getting dizzy and light headed feeling like I was going to pass out. I have never had a reaction from any vaccines previously.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Pruritus, Rash
Clinical narrative: First off the injection was not given in my deltoid muscle it was given in my bicep. Within 15 minutes of getting the vaccine I had gotten a white raised hive around the injection site that became very itchy and I began to get a red rash around the hive that was irregular. It quickly became bigger and became raised over the next few hours. It was extremely hot to the touch and painful, unlike any flu vaccine I've ever received. The next two days it continuously got bigger and more red wrapping around my arm. I went to urgent care on Sunday and it measured 9cm by 12cm. It was still very hot to the touch and bright red, itchy and painful. I was having shooting pain down my arm, numbness in my hand and fingers and itching in my hand and fingers. On Saturday night I had gotten a rash on the right side of my face and neck. From Friday night on I kept getting dizzy and light headed feeling like I was going to pass out. I have never had a reaction from any vaccines previously.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Pyrexia, Skin warm
Clinical narrative: Fever 101 F not responsive to acetaminophen; localized swelling, erythema, hot and painful to touch; Treated with continued acetaminophen, oxycodone, and hot packs.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Fever 101 F not responsive to acetaminophen; localized swelling, erythema, hot and painful to touch; Treated with continued acetaminophen, oxycodone, and hot packs.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Balance disorder, Burning sensation, Electrocardiogram, Fatigue
Clinical narrative: On Sept 11, 2018 (the day after receiving FLUARIX) patient began "to have sweats, felt sick, odd sensations, prickling in feet and difficulty with workout". By Sept 24, "half of mouth and tongue went numb. Left arm, shoulder, and neck seized. Blood pressure became abnormally high". On Sept 25th, she "saw a Dr for an EKG and stroke check. Lots of pain on left side, tongue felt scalded for a week". On Sept 30th, she "began a new blood pressure medication". On October 3rd, she "was admitted to the hospital with a blood pressure of 226/130, was rechecked for stroke and heart problems (tests came back negative). Blood pressure resistant to lowering. Started on more blood pressure and some anxiety medications. On Oct 5th, she was released from hospital. Patient reports that she "continued to get weaker, lots of reactions to medications, spent 2 weeks going to the Dr, laying on couch, having difficulty eating, and tongue feeling like tripping over it when talking. Basement stairs felt like a mountain. Lots of burning tingling and cramping at night, full body shaking, and balance off."  From Oct 17 through 22, "full facial numbness, made my teeth hurt".  Patient indicates "starting to improve but muscles still weak, fatigued easily, and still nighttime numbness and tingling". She has been referred to see a neurologist in December.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Flank pain, Hyperhidrosis, Hypertension, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: On Sept 11, 2018 (the day after receiving FLUARIX) patient began "to have sweats, felt sick, odd sensations, prickling in feet and difficulty with workout". By Sept 24, "half of mouth and tongue went numb. Left arm, shoulder, and neck seized. Blood pressure became abnormally high". On Sept 25th, she "saw a Dr for an EKG and stroke check. Lots of pain on left side, tongue felt scalded for a week". On Sept 30th, she "began a new blood pressure medication". On October 3rd, she "was admitted to the hospital with a blood pressure of 226/130, was rechecked for stroke and heart problems (tests came back negative). Blood pressure resistant to lowering. Started on more blood pressure and some anxiety medications. On Oct 5th, she was released from hospital. Patient reports that she "continued to get weaker, lots of reactions to medications, spent 2 weeks going to the Dr, laying on couch, having difficulty eating, and tongue feeling like tripping over it when talking. Basement stairs felt like a mountain. Lots of burning tingling and cramping at night, full body shaking, and balance off."  From Oct 17 through 22, "full facial numbness, made my teeth hurt".  Patient indicates "starting to improve but muscles still weak, fatigued easily, and still nighttime numbness and tingling". She has been referred to see a neurologist in December.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Loss of personal independence in daily activities, Malaise, Mobility decreased, Muscle spasms
Clinical narrative: On Sept 11, 2018 (the day after receiving FLUARIX) patient began "to have sweats, felt sick, odd sensations, prickling in feet and difficulty with workout". By Sept 24, "half of mouth and tongue went numb. Left arm, shoulder, and neck seized. Blood pressure became abnormally high". On Sept 25th, she "saw a Dr for an EKG and stroke check. Lots of pain on left side, tongue felt scalded for a week". On Sept 30th, she "began a new blood pressure medication". On October 3rd, she "was admitted to the hospital with a blood pressure of 226/130, was rechecked for stroke and heart problems (tests came back negative). Blood pressure resistant to lowering. Started on more blood pressure and some anxiety medications. On Oct 5th, she was released from hospital. Patient reports that she "continued to get weaker, lots of reactions to medications, spent 2 weeks going to the Dr, laying on couch, having difficulty eating, and tongue feeling like tripping over it when talking. Basement stairs felt like a mountain. Lots of burning tingling and cramping at night, full body shaking, and balance off."  From Oct 17 through 22, "full facial numbness, made my teeth hurt".  Patient indicates "starting to improve but muscles still weak, fatigued easily, and still nighttime numbness and tingling". She has been referred to see a neurologist in December.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Paraesthesia, Paraesthesia oral, Sensory disturbance, Toothache
Clinical narrative: On Sept 11, 2018 (the day after receiving FLUARIX) patient began "to have sweats, felt sick, odd sensations, prickling in feet and difficulty with workout". By Sept 24, "half of mouth and tongue went numb. Left arm, shoulder, and neck seized. Blood pressure became abnormally high". On Sept 25th, she "saw a Dr for an EKG and stroke check. Lots of pain on left side, tongue felt scalded for a week". On Sept 30th, she "began a new blood pressure medication". On October 3rd, she "was admitted to the hospital with a blood pressure of 226/130, was rechecked for stroke and heart problems (tests came back negative). Blood pressure resistant to lowering. Started on more blood pressure and some anxiety medications. On Oct 5th, she was released from hospital. Patient reports that she "continued to get weaker, lots of reactions to medications, spent 2 weeks going to the Dr, laying on couch, having difficulty eating, and tongue feeling like tripping over it when talking. Basement stairs felt like a mountain. Lots of burning tingling and cramping at night, full body shaking, and balance off."  From Oct 17 through 22, "full facial numbness, made my teeth hurt".  Patient indicates "starting to improve but muscles still weak, fatigued easily, and still nighttime numbness and tingling". She has been referred to see a neurologist in December.