chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Hyperhidrosis
Clinical narrative: 10/05/17: 1900 muscle weakness in left arm and general tiredness; 2100 whole body weakness and general tiredness; 2200 whole body fatigue and aches, tiredness, and fever; 2300 whole body aches, fever, chills, diaphoresis, GI discomfort. 10/06/17: 0100 drank fluids and decaffeinated tea, took 400 mg Ibuprofen. 10/07/17: 0900 previous symptoms became more mild and tolerable; fever broke during sleep. 10/21/17: 0800 pain similar to a bursitis in left shoulder. 10/21/17: 0830 applied heating pad with little relief; 400 mg Ibuprofen provided more relief, but discomfort persisted. This bursitis-like pain (discomfort and pain while lifting left arm above level of abdomen) has persisted since 10/21/17. It is more bearable on 11/09/17 at 1500, but it is still uncomfortable. I have done nothing (i.e. physical sports, injuries, activities) to believe that this shoulder pain was a result of physical motion.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain, Pyrexia
Clinical narrative: 10/05/17: 1900 muscle weakness in left arm and general tiredness; 2100 whole body weakness and general tiredness; 2200 whole body fatigue and aches, tiredness, and fever; 2300 whole body aches, fever, chills, diaphoresis, GI discomfort. 10/06/17: 0100 drank fluids and decaffeinated tea, took 400 mg Ibuprofen. 10/07/17: 0900 previous symptoms became more mild and tolerable; fever broke during sleep. 10/21/17: 0800 pain similar to a bursitis in left shoulder. 10/21/17: 0830 applied heating pad with little relief; 400 mg Ibuprofen provided more relief, but discomfort persisted. This bursitis-like pain (discomfort and pain while lifting left arm above level of abdomen) has persisted since 10/21/17. It is more bearable on 11/09/17 at 1500, but it is still uncomfortable. I have done nothing (i.e. physical sports, injuries, activities) to believe that this shoulder pain was a result of physical motion.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe Headache (7/10) and neck stiffness/aches, excessive tiredness at 12 hours post-injection.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site is swollen and red.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Peripheral swelling, Pruritus, Skin exfoliation, Swelling
Clinical narrative: Pt received vaccine on 10/20/2017 in afternoon. That evening pt C/O itching and swelling to hands, neck, bra line, feet and arms. Pt noticed blisters around 11/2/17 to bilateral thumbs. Itching and swelling to hands and fingers noticed 11/9/17 while at work, removed rings on fingers and noticed blisters and peeling skin to R ring finger. Seen as pt in Employee Health on 11/9/17.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Dyspnoea, Electrocardiogram, Hyperhidrosis, Thirst decreased
Clinical narrative: Loss appetite, Lack of thirst, Sweating, Couldn't breathe. Pt was hospitalized for 3 days.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray
Clinical narrative: Loss appetite, Lack of thirst, Sweating, Couldn't breathe. Pt was hospitalized for 3 days.
Age: 31.0
Sex: M
Vaccine: FLUC4, HEPAB
Symptoms: Wrong drug administered
Clinical narrative: When the technician was setting the Patient up to receive the Influenza Vaccine she reached into the refrigerator and accidently grabbed the wrong vaccine. Do to the amount of patient waiting she was moving too fast and missed the Five rights. She noticed the vaccines was not the correct one as soon as she pushed the plunger.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: She broke out in a rash that had bumps under the skin and redness. It was on her cheeks and chest and arms and it itches. It was still there after a week and that's when she reported it to me. She wasn't even going to tell me but her husband made her tell me. She says she is sensitive to a lot of medication anyway.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Injection site rash, Nausea
Clinical narrative: I had a rash around the injection site. Had a allergic reaction. My eyes swelled and my arm swelled up very large. Followed by minor trouble breathing and nausea.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling
Clinical narrative: I had a rash around the injection site. Had a allergic reaction. My eyes swelled and my arm swelled up very large. Followed by minor trouble breathing and nausea.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Severe pain in left shoulder/deltoid when raising above head.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine was given at 0930 am. About 5 pm, patient noticed a red area at the site of injection. It was warm to the touch and sore. Area measured 3 in x 6 in. Patient did not use anything to treat the area.  She continued to watch the area and it completely resolved by 5 days after administration.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 19 year-old (currently 22 year-old) female patient. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. Approximately on an unspecified date in 2012 (reported as "five years ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, lot number, expiration date were not reported) intramuscularly, for prophylaxis. Approximately on an unspecified date in 2014 (reported as "three years ago"), the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, lot number, expiration date were not reported) intramuscularly, for the same indication. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Atrial fibrillation, Influenza, Pneumonia, Vaccination failure
Clinical narrative: This spontaneous report was received from a 74 year old patient of unknown gender, reporting on her/himself; via Pfizer. The patient's medical history included pneumonia or the flu every winter, concurrent conditions and concomitant medication were not reported. In October 2016 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (unknown manufacturer), (strength, route, dose, lot# and expiration date were not reporter) for prophilaxis. Approximately in June 2017 (reported as: this summer) the patient experienced atrial fibrillation. Additionally, the patient reported that approximately in December 2016 (reported as: every winter) the patient experienced pneumonia or the flu even after receiveing pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of atrial fibrillation, influenza and pneumonia was unknown. The causal relationship between PNEUMOVAX 23 and the events was not provided. Upon internal review atrial fibrillation and pneumonia were determined to be medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 26-FEB-2014 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUN-2016 the patient was treated a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed famciclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 06-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown), subcutaneous on or about 30-NOV-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-NOV-2016, the patient was treated at an emergency department, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to zoster outbreaks. The patient has been prescribed gabapentin, lidocaine and hydrocodone-acetaminophen for management of her symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Mom called office and let RN know about reaction. Stated child's leg " blew up like a balloon" and noticed red bumps on his leg. Mom took child to ER and they administered Benadryl. Mom stated swelling today 1/9 has improved. Complaints of red bumps and itching currently but has improved.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Headache
Clinical narrative: Sever pain in right eye with headache.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient states her arm swelled to three times the size, it was painful.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Ultrasound scan
Clinical narrative: Pt was taking ibuprofen and heat treatment to help alleviate pain. Pt contacted pharmacy morning of 11/09/2017. Pt stated she was having severe pain and scheduled an appointment with her PCP for later in the day. Physician prescribed Rx for tramadol and possible follow up on 11/13/2017 if pain persists.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Ultrasound scan
Clinical narrative: Pt was taking ibuprofen and heat treatment to help alleviate pain. Pt contacted pharmacy morning of 11/09/2017. Pt stated she was having severe pain and scheduled an appointment with her PCP for later in the day. Physician prescribed Rx for tramadol and possible follow up on 11/13/2017 if pain persists.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hives around the local injection site 3 days after receiving a flu shot. Hive symptoms lasted 5 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Facial paralysis, Laboratory test normal
Clinical narrative: Left Bells Palsy.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hives around the local injection site 3 days after receiving a flu shot. Hive symptoms lasted 5 days.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Erythema, Induration, Limb mass, Peripheral swelling
Clinical narrative: Caused hardened lump surrounded by swelling and redness throughout entire arm and left-breast-area. Pain now moving to back.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse effects of the vaccination. This is to report that patient received a 3rd dose of Hepatitis A vaccine, unknowing that she had already received 2 doses prior to that day. No treatment necessary. Parents are aware of the event.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder pain since the injection on 9-27-17. Worse at night.
Age: 17.0
Sex: F
Vaccine: FLUX, MENB
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccination was given to a pregnant teen prior to the fact that it was known that she was pregnant.
Age: 74.0
Sex: M
Vaccine: FLUR3
Symptoms: Dizziness
Clinical narrative: Light-headedness started about 11:00 AM, the morning after receiving the shot the previous afternoon. I still have some light-headedness even after a two-nap this afternoon.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Lymph node pain, Pain, Peripheral swelling
Clinical narrative: Swelling of upper arm from shoulder to elbow, red, swollen, burning sensation, lasted two days. Lymph node in neck tender. Treated with ice packs and TYLENOL but was very painful.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site pustule
Clinical narrative: MD CALLED THE PHARMACY TO INFORM THAT THE PATIENT HAD POSTULES ON THE LEFT ARM WHERE THE PNEUMOVAX WAS INJECTED.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cold sweat, Loss of consciousness, Pallor, Syncope
Clinical narrative: POST DONATION, IMMEDIATLY FOLLOWING TDAP WENT TO DONOR FLOOR TO BEGIN WORKING. GOT FAINT LOC X 20 SECONDS STAFF MEMBERS EASED HER TO FLOOR, PALLOR, CLAMMY- RAPIDLY RECOVERED ALERT/ORIENTED X3 BP AT START 84/55-85, 101/69,AT TIME OF DISCHARGE 101/81-85 STATED THAT WAS HER NORM, CONSUMED 20ML'S OF POWERADE. SHE FELT BETTER. STRONG STEADY GAIT.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anxiety, Asthenia, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: POST DONATION, IMMEDIATLY FOLLOWING TDAP WENT TO DONOR FLOOR TO BEGIN WORKING. GOT FAINT LOC X 20 SECONDS STAFF MEMBERS EASED HER TO FLOOR, PALLOR, CLAMMY- RAPIDLY RECOVERED ALERT/ORIENTED X3 BP AT START 84/55-85, 101/69,AT TIME OF DISCHARGE 101/81-85 STATED THAT WAS HER NORM, CONSUMED 20ML'S OF POWERADE. SHE FELT BETTER. STRONG STEADY GAIT.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pallor, Peripheral coldness
Clinical narrative: POST DONATION, IMMEDIATLY FOLLOWING TDAP WENT TO DONOR FLOOR TO BEGIN WORKING. GOT FAINT LOC X 20 SECONDS STAFF MEMBERS EASED HER TO FLOOR, PALLOR, CLAMMY- RAPIDLY RECOVERED ALERT/ORIENTED X3 BP AT START 84/55-85, 101/69,AT TIME OF DISCHARGE 101/81-85 STATED THAT WAS HER NORM, CONSUMED 20ML'S OF POWERADE. SHE FELT BETTER. STRONG STEADY GAIT.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Within 1 hour of receiving vaccine felt dizzy, lightheaded, "like a cloud over" him. Then w/in 2 hrs nausea, respiratory congestion, yellow mucous, nausea, no appetite, diarrhea, and total body aches which continued into the next day (11/9/17).
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Respiratory tract congestion, Secretion discharge
Clinical narrative: Within 1 hour of receiving vaccine felt dizzy, lightheaded, "like a cloud over" him. Then w/in 2 hrs nausea, respiratory congestion, yellow mucous, nausea, no appetite, diarrhea, and total body aches which continued into the next day (11/9/17).
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Culture, Full blood count, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: The patient has 2 blisters to the right upper arm. She received BEXSERO and MENVEO yesterday. She took off the Band Aids at 1:00 pm today and noticed the blisters. She has not felt pain at the site.  There is erythema and mild swelling. She denies fever. She states that she has not had shortness of breath or wheezing. She denies facial swelling. No other concerns. Patient was given BACTROBAN ointment, BENADRYL, and TYLENOL. Cephalexin tablet.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received the injection and 2 hours later his arm started to hurt and then his arm turned bright red and started swelling. This morning his redness is gone and the swelling has gone down a lot but still present. Arm is still very sore.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: (The clinic online Epic/MyChart systems shows this as Influenza (FLUARIX) 4V 0.5mL PF 19+ yrs). I received the immunization on Monday 06NOV2017. I've been getting these every year in the fall for the past 5 years. When I got out of bed two days later, on Wednesday 08NOV2017 I had dizziness similar to a bout of vertigo I had in January 2012, and again in January 2013. This is a mild case of that, compared to the two previous instances. Coincidentally, I probably received the influenza vaccination in the days/weeks before those two episodes. In 2012 I was seen at a dizziness and balance center and evaluated. I had the test with the goggles to check for nystagmus (sp) and I did not have that. Rather, I likely had a vestibular virus that "reprogrammed" me. I recall that I was told that I didn't have crystals or "ear rocks". I did not require the canalith repositioning procedure. So I went through vestibular rehabilitation with a lot of walking and eye movements and successfully "learned" my changed inner ear. When I had an episode in January 2013 it was not as severe and I did the rehab myself, with good results in a few weeks. This current episode is the mildest I've ever had and I'm doing a DIY rehab. If it doesn't work I'll contact my doctor.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Impaired work ability, Malaise, Pain
Clinical narrative: After pt left, started feeling cold. Arm was red and started swelling. Next day arm was really hot and didn't feel well. Pt missed work due to not feeling well. Then from then on it has been sore and tender. Today  (11/9) pt returned to work. we observed her arm and it is real red and swollen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: After pt left, started feeling cold. Arm was red and started swelling. Next day arm was really hot and didn't feel well. Pt missed work due to not feeling well. Then from then on it has been sore and tender. Today  (11/9) pt returned to work. we observed her arm and it is real red and swollen.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Peripheral swelling, Tenderness
Clinical narrative: Patient had flu shot yesterday (11/8/17) - today (11/9/17) whole upper arm lateral aspect turned red from deltoid area to elbow bright red with mild swelling - mildly tender - no fever - no Hx of past RXN like this; Imp Intense local RXN to flu vaccination; instructed to use MOTRIN and ice pack.  MD advised patient to return for follow-up should condition worsen.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Per the client on the day after receiving her Meningococcal vaccine (MENVEO) around 1 pm she developed a headache that has not gone away. She also felt hot to the touch but felt cold inside of her body. She did not take her temperature. Injection site left deltoid area became red, swollen, sore with red bumps that are going away. The injection site is getting better. The client was advised to see her primary care provider. She does not have one. She is in college and was advised to go to the health center. If her symptoms get worse to go to the ER or call 911.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Skin warm
Clinical narrative: Per the client on the day after receiving her Meningococcal vaccine (MENVEO) around 1 pm she developed a headache that has not gone away. She also felt hot to the touch but felt cold inside of her body. She did not take her temperature. Injection site left deltoid area became red, swollen, sore with red bumps that are going away. The injection site is getting better. The client was advised to see her primary care provider. She does not have one. She is in college and was advised to go to the health center. If her symptoms get worse to go to the ER or call 911.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in on 11/9/2017 and reported a 3inch diameter circle around the injection site on her L arm (area was red, hot to the touch, and slightly swollen). Patient stated she was not bothered by it and there was not much pain. Patient was informed to take a Benadryl to see if it will help reduce the reaction and a pharmacist will follow up with her on Saturday 11/11/2017. She was informed if the reaction got worse to seek medical help.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient is complaining of arm numbness and pain for 4 weeks after getting the flu shot. He does not have full mobility or grip of his left arm/hand. He is going to follow up with a doctor for further review.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient reported swelling and pain in left shoulder muscle. Patient went to doctor for resolution. On November 9th patient reports shoulder muscle feels better.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Erythema, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Immediately felt rush of pain to head, head pressure, not dizzy but very off, hard to stand; eventually walked away from retail clinic and felt bad for 1 day - had local arm swelling, pain, redness for 1 week.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Immediately felt rush of pain to head, head pressure, not dizzy but very off, hard to stand; eventually walked away from retail clinic and felt bad for 1 day - had local arm swelling, pain, redness for 1 week.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: Severe pain in right shoulder. Limited movement. Fever. Chills. Sweats. Fatigue, loss of appetite. Nauseous. Unable to sleep. NORCO from my back surgery. Meloxicam arrived the next day. Ice. Cool cloth on my head. Heat when chilled. Bed rest when could get comfortable. Fluids. Most symptoms have slowly decreased. 3 1/2 days later. The pain was severe and now is moderate. Still can't lift my hand above my waist or reach more than a few inches. Constant pain in my upper arm and shoulder.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: Severe pain in right shoulder. Limited movement. Fever. Chills. Sweats. Fatigue, loss of appetite. Nauseous. Unable to sleep. NORCO from my back surgery. Meloxicam arrived the next day. Ice. Cool cloth on my head. Heat when chilled. Bed rest when could get comfortable. Fluids. Most symptoms have slowly decreased. 3 1/2 days later. The pain was severe and now is moderate. Still can't lift my hand above my waist or reach more than a few inches. Constant pain in my upper arm and shoulder.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: 11/9 patient called and stated: 11/6 pain shooting thru arm, 11/7 low grade fever 99.3, 11/8 tired. Rash developed from about 2 to 3 inches from top of shoulder to almost to elbow and trying to go around to underside of arm. Bright red. Also hurt under her arm like in her lymph node areas. Wanted to know which shot was on the bottom. That's where the reaction occurred. The FLUZONE was given in the bottom of the injection site. She then remember what I have listed in the previous boxes.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: 11/9 patient called and stated: 11/6 pain shooting thru arm, 11/7 low grade fever 99.3, 11/8 tired. Rash developed from about 2 to 3 inches from top of shoulder to almost to elbow and trying to go around to underside of arm. Bright red. Also hurt under her arm like in her lymph node areas. Wanted to know which shot was on the bottom. That's where the reaction occurred. The FLUZONE was given in the bottom of the injection site. She then remember what I have listed in the previous boxes.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Inflammatory marker increased, Injection site pain, Mobility decreased
Clinical narrative: Pt called on 11/9/2017 regarding medication. In speaking with the pt. It was mentioned that she wished to report a VAE that had begun about one week after the vaccine. She stated that it began with typical soreness in the left arm deltoid from the shoulder area to the elbow area. After about a week she noticed that it began to also be sore in her other arm. At this point she began to notice soreness in both arm muscles and joints as well as her hips and legs. Pt said that the soreness and pain is so severe that she can hardly move at night and in the morning. Her muscles are very sore to the point of causing her to feel weak. Pt states it has taken a toll on her QOL.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt called on 11/9/2017 regarding medication. In speaking with the pt. It was mentioned that she wished to report a VAE that had begun about one week after the vaccine. She stated that it began with typical soreness in the left arm deltoid from the shoulder area to the elbow area. After about a week she noticed that it began to also be sore in her other arm. At this point she began to notice soreness in both arm muscles and joints as well as her hips and legs. Pt said that the soreness and pain is so severe that she can hardly move at night and in the morning. Her muscles are very sore to the point of causing her to feel weak. Pt states it has taken a toll on her QOL.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchiness the next day followed by red raised area roughly 2 to 3 inches in diameter on bicep starting about 1/2 inch above elbow. No visible reaction directly surrounding the injection site.
Age: 5.0
Sex: M
Vaccine: FLU4, IPV, MMR
Symptoms: Decreased appetite, Eyelid oedema, Facial pain, Fatigue, Headache
Clinical narrative: Shots given 10/30/17 Monday on 11/06/17 Monday left side cheek pain began on 11/7/17 stick neck developed and top of head and rear of head pain. Pressure to get off bed was too much. 11/8/17 left side of face and eye lid swollen and cheek pain. Loss of appetite and tiredness  since 11/6/17.
Age: 5.0
Sex: M
Vaccine: FLU4, IPV, MMR
Symptoms: Musculoskeletal discomfort, Swelling face
Clinical narrative: Shots given 10/30/17 Monday on 11/06/17 Monday left side cheek pain began on 11/7/17 stick neck developed and top of head and rear of head pain. Pressure to get off bed was too much. 11/8/17 left side of face and eye lid swollen and cheek pain. Loss of appetite and tiredness  since 11/6/17.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Patient received vaccine 11/02/2017; presented to pharmacy 11/09/2017 reporting that the day the vaccine was given her arm was red and swollen; she applied ice; redness and swelling reduced still some redness remaining as well as soreness and itchiness.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The patient received the FLUZONE HD vaccine on 9/23/17. On 11/7/17 she came to the pharmacy and reported that she has had continuous muscle soreness in her left deltoid since the vaccine was given and that she has difficulty raising her arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash on back of left hand. Patient self treated with hydrocortisone and it is resolving. Patient also stated that the first night she had an episode of shortness of breath and needed to use her inhaler. Which resolved in one inhalation and about 5 minutes
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Patient came to the pharmacy and showed me a lump close to the area where she got her shot. I felt the lump it was hard. The center was harder than the surrounding area. The diameter was about 1.5 inches. Patient stated that it was not sore so she didn't know exactly when it started. She was guessing about 2-3 days ago. I advised patient if it gets worse in a day or two, then she should contact MD as well as the pharmacy.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: ARM ON PNEUMOVAX SITE WAS RED AND SWOLLEN FROM INJECTION SITE TO WRIST. ADVISED PATIENT TO USE ICE PACK, BENADRYL, AND IBUPROFEN AND CONTACT MD TO ADVISE ON ANY FURTHER TREATMENT.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Severe pain upon raising arm laterally, warm compress felt better, ice did not, has since resolved--this was to PNEUMOVAX 23.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, C-reactive protein normal, Full blood count abnormal, Gait inability, Injection site pain
Clinical narrative: Myositis at site of injection - swelling, pain and inability to walk in that leg. Myositis worsened 10 days after the vaccination.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Myositis, Red blood cell sedimentation rate normal, Vaccination site pain
Clinical narrative: Myositis at site of injection - swelling, pain and inability to walk in that leg. Myositis worsened 10 days after the vaccination.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray abnormal
Clinical narrative: Myositis at site of injection - swelling, pain and inability to walk in that leg. Myositis worsened 10 days after the vaccination.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain starting shortly after receiving shot. Injection given too high, into shoulder. Pain goes from back left shoulder blade down to left elbow. Holding shoulder forward with difficulty moving back to proper location. Limit and stiff range of motion and strength. Starting physical therapy per drs recommendation and taking oral steroids currently.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Patient began to get a fever of 100 F the evening of his vaccination 11/7/17. Motrin was given and  pt went to bed. His fever was 102 F the next morning 11/8/17. Motrin was given and doctor appointment made. His temperature was normal at 9:30am at doctor office. Then that evening (11/8/17) his fever came back to 102F. Motrin was given and he went to bed. His temperature was 99F at midnight. Then fever 102 again the morning of 11/9/17. Motrin alternating with Tylenol given  rest of day. Finally normal at bedtime 11/9/17.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dizziness, Fatigue, Hypoacusis, Syncope
Clinical narrative: Within a couple minutes of receiving the vaccine, she reported that she could not hear, felt very tired, and was about to faint. She collapsed and was kneeling on the floor, holding my legs for support. She began to cough and vomited a small amount. She repeated that she felt like she was about to pass out. After about 15 min she recovered sufficiently to walk to the car and we drove home.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Within a couple minutes of receiving the vaccine, she reported that she could not hear, felt very tired, and was about to faint. She collapsed and was kneeling on the floor, holding my legs for support. She began to cough and vomited a small amount. She repeated that she felt like she was about to pass out. After about 15 min she recovered sufficiently to walk to the car and we drove home.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Flushing, Immediate post-injection reaction
Clinical narrative: IMMEDIATE FACIAL AND EAR FLUSHING. NO URTICARIA. NO FUSSINESS OR ITCHING. NO COUGH OR WHEEZE, NO VOMITING. REDNESS LASTED LONGER THAN 15 MIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site swelling
Clinical narrative: 20 x 12 skin color raised elevated patch (non itchy) at the site of PROQUAD.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Mother reports pt. had mild rash to (R) arm evening of shot and "itching". By next night (R) torso also covered in rash and pt. reports "itching".
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Mobility decreased, Pain in extremity
Clinical narrative: R arm is sore - cannot lift arm (R) arm - abdominal pain.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Pt came in with her daughter and daughter informed one that since 11/4/17 pt arm was itchy, red, bruised, swelling and hot to the touch. States tried hot compress but did not work so tried cold compress. Cold compress worked. Informed daughter to massage. 11/9/17 spoke to daughter, pt doing much better.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right arm red, swollen, afebrile.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint crepitation
Clinical narrative: After injection pt. had pain in shoulder (left). Pain has not gone away since injection on 9/30/17. Gets "clicking" noise and difficult to raise arm over head.
Age: 24.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, slightly warm patch noticed on L upper deltoid when student came in for additional immunizations. Per student-had received TDAP and Hep B prior week, stated S/S had been here for a few days.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient woke up on 11/09/2017 with redness, warmth, and pain at the site. Today less red, still warm and hard at the site, not painful. Treatment: ZYRTEC, ice pack.
Age: 0.42
Sex: U
Vaccine: RV5, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 5-month-old patient, who on 22-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 428 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
Age: 76.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Diarrhoea, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelling, tenderness, feeling hot, pruritis, pyrexia, nausea, diarrhea.
Age: 76.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Nausea, Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Right arm swelling, tenderness, feeling hot, pruritis, pyrexia, nausea, diarrhea.
Age: 76.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Diarrhoea, Feeling hot, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Right arm swelling, tenderness, feeling hot, pruritis, pyrexia, nausea, diarrhea.
Age: 76.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Right arm swelling, tenderness, feeling hot, pruritis, pyrexia, nausea, diarrhea.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Hypersomnia, Injection site erythema, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient of unknown age. The patient had no drug reactions or allergies. No information regarding the patient's medical history and concurrent conditions was provided. On 05-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N013541, expiration date: 23-JAN-2019, as a routine immunisation (dose and route of administration were not provided). Concomitant therapies included simvastatin (manufacturer unknown) and oxybutynin. On an unknown date in 2017 (reported as "soon after receiving PNEUMOVAX 23"), the patient experienced swelling and a red itchy rash on the inner upper arm that spanned from the axilla to the antecubital space. On an unknown date in 2017, the patient's arm was also warm to the touch. The patient visited a pharmacy. No treatment was given for the reported events. The pharmacist reported that the patient was fully recovered at the reporting time. The causal relationship between the events and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient of unknown age. The patient had no drug reactions or allergies. No information regarding the patient's medical history and concurrent conditions was provided. On 05-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N013541, expiration date: 23-JAN-2019, as a routine immunisation (dose and route of administration were not provided). Concomitant therapies included simvastatin (manufacturer unknown) and oxybutynin. On an unknown date in 2017 (reported as "soon after receiving PNEUMOVAX 23"), the patient experienced swelling and a red itchy rash on the inner upper arm that spanned from the axilla to the antecubital space. On an unknown date in 2017, the patient's arm was also warm to the touch. The patient visited a pharmacy. No treatment was given for the reported events. The pharmacist reported that the patient was fully recovered at the reporting time. The causal relationship between the events and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient of unknown age. The patient had no drug reactions or allergies. No information regarding the patient's medical history and concurrent conditions was provided. On 05-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N013541, expiration date: 23-JAN-2019, as a routine immunisation (dose and route of administration were not provided). Concomitant therapies included simvastatin (manufacturer unknown) and oxybutynin. On an unknown date in 2017 (reported as "soon after receiving PNEUMOVAX 23"), the patient experienced swelling and a red itchy rash on the inner upper arm that spanned from the axilla to the antecubital space. On an unknown date in 2017, the patient's arm was also warm to the touch. The patient visited a pharmacy. No treatment was given for the reported events. The pharmacist reported that the patient was fully recovered at the reporting time. The causal relationship between the events and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in both right and left shoulders, very limited range of motion, can't lift arms over head, fatigue muscle weakness, can'sleep, can't move covers of or on me without severe pain, a few headaches. This has lasted for 21 days and no relief. Went to walk in clinic, Orthopedic surgeon and have to see a rheumatologist on 11-15-17 Had Medrol Dospak from walk in clinic and it helped until it wore off and have the same original symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13, FLU4
Symptoms: Arthropathy, Condition aggravated, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Severe pain in both right and left shoulders, very limited range of motion, can't lift arms over head, fatigue muscle weakness, can'sleep, can't move covers of or on me without severe pain, a few headaches. This has lasted for 21 days and no relief. Went to walk in clinic, Orthopedic surgeon and have to see a rheumatologist on 11-15-17 Had Medrol Dospak from walk in clinic and it helped until it wore off and have the same original symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13, FLU4
Symptoms: Injection site pain, Muscular weakness, Poor quality sleep
Clinical narrative: Severe pain in both right and left shoulders, very limited range of motion, can't lift arms over head, fatigue muscle weakness, can'sleep, can't move covers of or on me without severe pain, a few headaches. This has lasted for 21 days and no relief. Went to walk in clinic, Orthopedic surgeon and have to see a rheumatologist on 11-15-17 Had Medrol Dospak from walk in clinic and it helped until it wore off and have the same original symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13, FLU4
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Mobility decreased
Clinical narrative: Severe pain in both right and left shoulders, very limited range of motion, can't lift arms over head, fatigue muscle weakness, can'sleep, can't move covers of or on me without severe pain, a few headaches. This has lasted for 21 days and no relief. Went to walk in clinic, Orthopedic surgeon and have to see a rheumatologist on 11-15-17 Had Medrol Dospak from walk in clinic and it helped until it wore off and have the same original symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13, FLU4
Symptoms: Muscular weakness, Musculoskeletal pain, X-ray limb
Clinical narrative: Severe pain in both right and left shoulders, very limited range of motion, can't lift arms over head, fatigue muscle weakness, can'sleep, can't move covers of or on me without severe pain, a few headaches. This has lasted for 21 days and no relief. Went to walk in clinic, Orthopedic surgeon and have to see a rheumatologist on 11-15-17 Had Medrol Dospak from walk in clinic and it helped until it wore off and have the same original symptoms.
Age: 1.33
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 23-MAY-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M046140 with expiration date on 27-SEP-2019 (dose and route of administration were not reported). Since 25-APR-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cold sweat, Loss of consciousness, Pallor, Syncope
Clinical narrative: Employee/donor donated 689 ml of plasma and received 500 ml of saline via venipuncture per policy without incident. Donor had TDAP shot administered shortly afterwards and returned to work approx. 15 min. later. Donor soon loss consciousness for approximately 20 sec and regained consciousness by the time medical staff associate arrived to assist. Donor's additional symptoms included: cold extremities, pallor, sweating, anxiety, dizziness/lightheadedness, nausea, and weakness. Initial BP 84/55 and pulse 81 bpm. Donor was given oral fluids (20 oz of powerade) after nausea had subsided, ice packs applied, and fanned donor to alleviate the warmth. Donor recovered quickly after receiving fluids. Vitals at time oral fluids were given was BP 101/69 and pulse 82. At time of release BP 108/81 and pulse 85. Donor left center in satisfactory condition and had no further issues or complaints at this time.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anxiety, Asthenia, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Employee/donor donated 689 ml of plasma and received 500 ml of saline via venipuncture per policy without incident. Donor had TDAP shot administered shortly afterwards and returned to work approx. 15 min. later. Donor soon loss consciousness for approximately 20 sec and regained consciousness by the time medical staff associate arrived to assist. Donor's additional symptoms included: cold extremities, pallor, sweating, anxiety, dizziness/lightheadedness, nausea, and weakness. Initial BP 84/55 and pulse 81 bpm. Donor was given oral fluids (20 oz of powerade) after nausea had subsided, ice packs applied, and fanned donor to alleviate the warmth. Donor recovered quickly after receiving fluids. Vitals at time oral fluids were given was BP 101/69 and pulse 82. At time of release BP 108/81 and pulse 85. Donor left center in satisfactory condition and had no further issues or complaints at this time.