chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 27-APR-2018, the patient was vaccinated with a dose of M-M-R II via intramuscular route (dose, lot number and expiration date were not reported) instead of subdermal route. No adverse effects were reported.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Computerised tomogram normal, Fall, Immediate post-injection reaction, Laceration, Seizure
Clinical narrative: This spontaneous report has been received from a medical assistant via a company representative referring to an approximately 17-year-old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Approximately in February 2018 (reported as "in February 2018 or March 2018") the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  Other suspect therapies included TRUMENBA. It was reported that immediately after vaccination, the patient fell off the bed and had a seizure. The patient was monitored at the physician's office for an unspecified period of time and then was sent to the emergency room. It was also mentioned that the patient had a cut above the eyebrow which was "glued" (face injury). On an unspecified date in 2018, a computed tomography (CT) of the head was performed which was normal. On an unspecified date in 2018, a follow up with the physician documented the patient was fine. At the reporting time, the outcome of seizure, fall and face injury was reported as resolved. The causality assessment between therapy with GARDASIL 9 and the events was not reported. Upon internal review, the seizure was determined to be medically significant.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Therapeutic procedure
Clinical narrative: This spontaneous report has been received from a medical assistant via a company representative referring to an approximately 17-year-old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Approximately in February 2018 (reported as "in February 2018 or March 2018") the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  Other suspect therapies included TRUMENBA. It was reported that immediately after vaccination, the patient fell off the bed and had a seizure. The patient was monitored at the physician's office for an unspecified period of time and then was sent to the emergency room. It was also mentioned that the patient had a cut above the eyebrow which was "glued" (face injury). On an unspecified date in 2018, a computed tomography (CT) of the head was performed which was normal. On an unspecified date in 2018, a follow up with the physician documented the patient was fine. At the reporting time, the outcome of seizure, fall and face injury was reported as resolved. The causality assessment between therapy with GARDASIL 9 and the events was not reported. Upon internal review, the seizure was determined to be medically significant.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Facial paralysis, Skin discolouration
Clinical narrative: Pt. initially crying with vaccines, but once vaccines were finished, pt. stopped crying, her face became still, lips drooped downward. She was looking at nurse but not blinking. Developed a dusky appearance, episode lasted less than 30 sec. Child loosened up, smiled and laid head on mom's chest. Normal color returned O2 sat 98%.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Heart rate increased
Clinical narrative: Fast heart rate, tiredness, headache, loss of appetite. No medical attn sought. Last seen at Dr office on 2/21/18.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 3rd May 2018, the patient experienced headache, nausea and fatigue. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the headache, nausea and fatigue were unknown. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the headache, nausea and fatigue to be related to SHINGRIX. Additional information was received as follows: On 2nd May 2018, at 17:30, the patient received SHINGRIX. The patient stated he awoke in the morning with the headache, fatigue and nausea to the point where he did not think he could drive. The patient stated that headache and fatigue have gotten worse over the day. The patient could not sleep on his right side last night due to the arm soreness. This case had been linked to the case US2018078810, reported by the same reporter (wife's case).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Photosensitivity reaction, Rash vesicular, Skin reaction, Vaccination complication
Clinical narrative: Vesicular rash in clusters on left upper arm in area where MENACTRA and TRUMENBA vaccines were administered on 05/04/2018. Differential might be herpetic rash, skin reaction secondary to immunizations, photodermasitis.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Myalgia
Clinical narrative: Severe headache, muscle aches around the shoulder/neck area, could not sleep all night.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Fat necrosis, Haematoma, Injection site discolouration, Injection site reaction
Clinical narrative: Red and swollen for a few days after injection, mother applied ice. On 5/9/18 (20 days later) came back to office, persistent 1cm subcutaneous nontender nodule at left deltoid injection site with slight grayish discoloration of skin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Skin mass, Swelling
Clinical narrative: Red and swollen for a few days after injection, mother applied ice. On 5/9/18 (20 days later) came back to office, persistent 1cm subcutaneous nontender nodule at left deltoid injection site with slight grayish discoloration of skin.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Redness & tender to touch at injection site. Fatigue & nausea for 48 hours status post injection.
Age: 29.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Chest discomfort, Hyperhidrosis, Hypoaesthesia, Somnolence
Clinical narrative: Patient reports she had numbness in her face, heaviness on her chest, sweating, and feels like she wants to sleep. LPNs and RN checked patient and called for Ambulance. Patient transported to Hospital to get checked out.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash erythematous, Rash macular, Rash pruritic, Urticaria
Clinical narrative: Client states that within 1.5 hours after vaccine administration, she experienced "hives" described as red blotchy rash on both arms which also began to itch. Went to the infirmary at the facility where vaccines were given and the doctor gave her an antihistamine. States the rash cleared up quickly and had no signs of respiratory distress. TWINRIX was scheduled to be given on 5/3/18 (on accelerated schedule) and this dose was deferred. Instructed pt to consult with her physician if she needs another dose.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia
Clinical narrative: Patient reporting numbness and decreased grip strength in her hands. She came to pharmacy initially to get non-safety caps to help her get her tops of the medication better as she was having difficulty. She said it started after receiving the vaccine. It has improved since date of intial start and is slowly getting better.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS (CHILLS, FEVER, MUSCLE ACHES).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Immediate ache and stiffness at injection site that is getting worse after 3 days. After 3 days all muscles in both arms and in my torso are aching. Impossible to turn over in bed due to stiffness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Immediate ache and stiffness at injection site that is getting worse after 3 days. After 3 days all muscles in both arms and in my torso are aching. Impossible to turn over in bed due to stiffness.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via Center regarding a baby of an unknown demographics. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, frequency, lot# and expiry date were not reported) route of administration was reported as unknown, for prophylaxis. On an unknown date, an office staff inadvertently administered an expired M-M-R II to the baby. The patient's relevant lab data was unknown. At the time of report (04-MAY-2018), it was unknown if the baby would continue to receive M-M-R II. It was reported that the baby was okay.
Sex: F
Vaccine: RV5
Symptoms: Exposure via skin contact, No adverse event, Product leakage, Product quality issue
Clinical narrative: This spontaneous report was received from a female health care professional (also reported as "administrator") of unknown age reporting on herself. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 07-MAY-2018, the physician accidentally touched a leaking ROTATEQ (lot number N021026, expiration date 24-FEB-2019, dosing tube.  No adverse effect reported. Product quality complaint filed. The action taken with ROTATEQ, the outcome of the event product quality complaint and the causal relationship between the event and therapy with ROTATEQ were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (route, dose, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. Later in 2016, the patient was treated by a family medicine physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown.  The lawyer felt that vaccination failure and herpes zoster were related to ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Dizziness, Insomnia, Muscle spasms, Pain in extremity
Clinical narrative: Patient developed severe pain in both arms and both legs, was unable to sleep due to the pain which then caused spasms in legs; following morning patient felt weak and lightheaded and fainted.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Syncope
Clinical narrative: Patient developed severe pain in both arms and both legs, was unable to sleep due to the pain which then caused spasms in legs; following morning patient felt weak and lightheaded and fainted.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Immediate post-injection reaction, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Two vaccines were given on 10/6/17 in the left arm. Patient felt pain immediately and he stated "something was not right."  Returned to office on 11/3/17 with Dr. who referred him to Orthopedics. Saw Orthopedics on 12/12/17 and also got an MRI. Patient did go to physical therapy for 4-5 visits with out help. Physical therapy sent him back to orthopedics. Was seen @ orthopedics on 5/2/18 and received another MRI on 5/5/18. Follow up appointment with orthopedics is on 5/9/18 to discuss further plans.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: On right leg a bullseye appearance 7 inches in size, itchy, painful, hard and hot to touch. Went to  Medical Center on 5/5/18. Was seen at primary care on 5/8/18 with some improvement to area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Colitis ulcerative
Clinical narrative: Flare of ulcerative colitis. Lasted x 1 month.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Fever (TMax 102.7), chills, body aches, diffuse myalgia, fatigue. Appeared within 24 hours of vaccination.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: After receiving all 4 vaccines, client immediately stated, "I don't feel good. I told her to put her head down and bring her knees to her chest. She then went limp for a few second, awoke and stated "wow what just happened?" 1429 Vital signs: B/P - 90/59, Pulse - 60 and respirations - 16. 1446 Vital Signs: B/P - 86/52, Pulse - 66 and respirations - 18.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash
Clinical narrative: Moderate pain throughout arm, took TYLENOL and pain slowly decreased over period of one week. Rash began and slightly spread over upper arm, patient was instructed to use BENADRYL/hydrocortisone cream. If no resolution to visit doctor office. Unknown resolution of rash as this was reported today to pharmacy. Instructed patient to please follow up with resolution.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 49.0
Sex: F
Vaccine: FLUA3
Symptoms: Anxiety, Injection site mass, Joint range of motion decreased, Musculoskeletal disorder, Musculoskeletal stiffness
Clinical narrative: Initially, pain and stiffness. Then pain, stiffness, decreased range of motion, small mass at site if injection, 3 weeks out- bicep "frozen", loss of use of entire arm. Since shot, 4 months out now, ongoing pain, with or without use, day or night intermittent, decreased range of motion (even with self-massage and stretching), under skin mass still present.
Age: 49.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: Initially, pain and stiffness. Then pain, stiffness, decreased range of motion, small mass at site if injection, 3 weeks out- bicep "frozen", loss of use of entire arm. Since shot, 4 months out now, ongoing pain, with or without use, day or night intermittent, decreased range of motion (even with self-massage and stretching), under skin mass still present.
Age: 77.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports possibly getting a PNEUMOVAX vaccine 8-12 years prior. 110 mm red, slightly raised reaction noted on inside right upper arm, not connected to injection site day after injection. Treated with ibuprofen with marked improvement.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Lethargy
Clinical narrative: I had the injection in the morning around 8 a.m. on a Friday. About 4 hours after the injection, the injection site became slightly red and very sore. About 12 hours after the initial injection (which would be Friday Evening), I developed a moderate level headache, mild nausea, general lethargy and overall achiness. 24 hours after the initial injection (which would have been Saturday Morning) the injection site became extremely red and warm to the touch along with general lethargy and the continuation of the moderate headache, nausea and overall achiness. Sunday Morning I felt a little bit better but still had mild side effects as listed above. By Monday morning, which would have been 72 hours later, pretty much all symptoms had disappeared and on Tuesday morning I was back to normal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: I had the injection in the morning around 8 a.m. on a Friday. About 4 hours after the injection, the injection site became slightly red and very sore. About 12 hours after the initial injection (which would be Friday Evening), I developed a moderate level headache, mild nausea, general lethargy and overall achiness. 24 hours after the initial injection (which would have been Saturday Morning) the injection site became extremely red and warm to the touch along with general lethargy and the continuation of the moderate headache, nausea and overall achiness. Sunday Morning I felt a little bit better but still had mild side effects as listed above. By Monday morning, which would have been 72 hours later, pretty much all symptoms had disappeared and on Tuesday morning I was back to normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient reported fever, chills, pain in fingers and toes. Arm extremely sore. Body feels extremely weak.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Gait disturbance, Headache, Injection site erythema
Clinical narrative: Extreme fatigue, headache, muscle and joint pain causing difficulty in moving and walking, nausea with vomiting, hot, red and swollen injection site, all treated with ibuprofen. Most severe pain and fatigue lasted from Saturday afternoon until Monday morning. In creasingly less fatigue and pain through Wednesday evening.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Myalgia, Nausea
Clinical narrative: Extreme fatigue, headache, muscle and joint pain causing difficulty in moving and walking, nausea with vomiting, hot, red and swollen injection site, all treated with ibuprofen. Most severe pain and fatigue lasted from Saturday afternoon until Monday morning. In creasingly less fatigue and pain through Wednesday evening.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Extreme fatigue, headache, muscle and joint pain causing difficulty in moving and walking, nausea with vomiting, hot, red and swollen injection site, all treated with ibuprofen. Most severe pain and fatigue lasted from Saturday afternoon until Monday morning. In creasingly less fatigue and pain through Wednesday evening.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Patient received the vaccine at pharmacy. Lot number, vaccine route unknown. Right shoulder red and swollen. Denies pain.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: Patient complained that immunization crippled him meaning he could hardly walk or move around.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Agitation, Anxiety, Catatonia, Communication disorder, Hypertension
Clinical narrative: Developed acute anxiety, tachycardia, hypertension ~ 48 hrs after vaccine (4/26/18). Was admitted overnight at Hospital due to uncertain origin of hypertension. Resolved, & was discharged. On 4/29, was noted to "not be herself," & became more agitated & less communicative over the course of the day. Was re-admitted to Hospital that evening for acute mental status changes. Was minimally responsive/catatonic for about 48-72 hrs. Extensive w/u ruled out infectious, toxic, metabolic causes. MRI showed mild acute L optic neuritis (Pt had no visual changes), but was otherwise normal. Was treated with high-dose steroids for possible acute encephalomyelitis, & began to improve. Was also discovered during her second admission that immediately prior to the first onset of anxiety & tachycardia on 4/26, patient had disclosed to her teacher a past episode of sexual assault - an event that had occurred about 5 years earlier. Final discharge diagnosis was acute catatonia secondary to trauma, and L optic neuritis of uncertain etiology. Multidisciplinary team unable to determine if the two were somehow related to each other, related to vaccine, or unrelated. Since no visual symptoms, neuro-ophthalmologist was unclear if MRI findings were clinically significant or not. As of today, patient continues to improve, but is not 100% back to her normal self yet. She will have a follow-up MRI & euro-ophthalmology visit within the next few weeks.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hyporesponsive to stimuli, Injury, Nuclear magnetic resonance imaging abnormal, Optic neuritis, Tachycardia
Clinical narrative: Developed acute anxiety, tachycardia, hypertension ~ 48 hrs after vaccine (4/26/18). Was admitted overnight at Hospital due to uncertain origin of hypertension. Resolved, & was discharged. On 4/29, was noted to "not be herself," & became more agitated & less communicative over the course of the day. Was re-admitted to Hospital that evening for acute mental status changes. Was minimally responsive/catatonic for about 48-72 hrs. Extensive w/u ruled out infectious, toxic, metabolic causes. MRI showed mild acute L optic neuritis (Pt had no visual changes), but was otherwise normal. Was treated with high-dose steroids for possible acute encephalomyelitis, & began to improve. Was also discovered during her second admission that immediately prior to the first onset of anxiety & tachycardia on 4/26, patient had disclosed to her teacher a past episode of sexual assault - an event that had occurred about 5 years earlier. Final discharge diagnosis was acute catatonia secondary to trauma, and L optic neuritis of uncertain etiology. Multidisciplinary team unable to determine if the two were somehow related to each other, related to vaccine, or unrelated. Since no visual symptoms, neuro-ophthalmologist was unclear if MRI findings were clinically significant or not. As of today, patient continues to improve, but is not 100% back to her normal self yet. She will have a follow-up MRI & euro-ophthalmology visit within the next few weeks.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient called pharmacy on 5/8 reporting that he thought he might be having a reaction to his vaccine he received on 5/6. He reported a large triangular area of his arm that was red, tender, and warm to the touch. He said it began the day after he got the vaccine. He came into the pharmacy on 5/9 to have the pharmacist inspect the site. Site of injection (left deltoid) is showing no signs of anything, but he does have a large red area, warm to touch, and tender, farther distal on the arm closer to the elbow. He had been to his dr office that day to have it looked at and they suggested he show pharmacist so we could report at AE of vaccine. Redness and tenderness seem to be getting better every day he reports. Confirmed with immunizing pharmacist that injection was definitely given IM in the deltoid.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth, Malaise, Nausea
Clinical narrative: FELT FINE THE DAY OF INJECTION, WITHIN THE NEXT 24 HOURS PATIENT EXPERIENCED FEVER, NAUSEA, MALAISE, WARM/RED INJECTION SITE. OVERALL FELT SICK AND HEAD FELT CLOUDY.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: FELT FINE THE DAY OF INJECTION, WITHIN THE NEXT 24 HOURS PATIENT EXPERIENCED FEVER, NAUSEA, MALAISE, WARM/RED INJECTION SITE. OVERALL FELT SICK AND HEAD FELT CLOUDY.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance
Clinical narrative: Next day was unsteady on her feet and had wobbly gait. Not due to pain at injection site. Was not favoring leg.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Redness across back and upper torso. Warm to the touch, no itchiness or pain.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: By 3 PM on the day of the injections I experienced severe fatigue, the following two days I had muscle aches, headache and shooting pains in my joints. I had chills, dizziness and no appetite.  The shots were given Tuesday AM. Wednesday I could not have driven a car, Thursday I improved slightly but did not feel that it would be safe to operate a car. On Friday I returned to the doctor's office and saw a Dr. who suspected an allergic reaction. I have continued to improve and feel normal again one week following the injections.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Headache, Hypersensitivity, Impaired driving ability, Myalgia
Clinical narrative: By 3 PM on the day of the injections I experienced severe fatigue, the following two days I had muscle aches, headache and shooting pains in my joints. I had chills, dizziness and no appetite.  The shots were given Tuesday AM. Wednesday I could not have driven a car, Thursday I improved slightly but did not feel that it would be safe to operate a car. On Friday I returned to the doctor's office and saw a Dr. who suspected an allergic reaction. I have continued to improve and feel normal again one week following the injections.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: PATIENT CALLED PHARMACY 2 HOURS LATER AND STATED THAT SHE GOT RASH ALL OVER HER BODY AND SOME SMALL RED BUMPS ON HER FACE. PATIENT WENT TO URGENT CARE AND GOT BENADRYL INJECTION AT URGENT CARE AND ZYRTEC TO TAKE AT HOME. PATIENT IS DOING FINE NOW. THE RASH ON BODY IS DISAPPEARING GRADUALLY.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Injection site slightly swollen, tender, achy for 3 days. Within 5 hours of inoculation headache, fever, achy muscles and joints for 2-3 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site slightly swollen, tender, achy for 3 days. Within 5 hours of inoculation headache, fever, achy muscles and joints for 2-3 days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Big red patch around injection site, not raised, itching. Recommended patient take benadryl capsules and use ice pack to help with redness and itching. Since patient also have appointment next day for health clinic (unrelated), also recommended she show to health care provider.
Age: 65.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Dyspnoea, Pharyngeal oedema, Speech disorder
Clinical narrative: Pt started to have sob, swelling of throat, and difficulty speaking. Pt was given 50mg of oral benedryl and 911 was called. Pt soon started to feel better after the benedryl and refused further medical treatment from paramedics.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen and bruised all below site where injection was given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Aggression, Sensory disturbance
Clinical narrative: 48 hours after vaccines, pt had increased aggressive behavior and heightened sensory issues which lasted 2 weeks, then back to baseline. Teacher called family on 4/11/18 to alert them that he was acting different.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Pain in shoulder has had multiple doctors visits for pain. Pain radiates to neck.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a rash 3 days after receiving the SHINGRIX vaccination. He saw his physician on 4/24 who confirmed the diagnosis of shingles. Patient is taking VALTREX.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea, Irritability, Skin warm, Somnolence
Clinical narrative: 5-9-18 at 3:30. Phone call from Grandmother who brought infant in for immunizations. States "crabby" evening of shots and yesterday. Today just wanting to sleep, feels like running a fever, had water diarrhea x3 this morning. No redness or swelling of injection sites. Advised Grandmother to seek medical attention either with infant's provider or Emergency Room.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Pain, Pruritus, Tenderness, Urticaria
Clinical narrative: 38mm welt, itching, warm feeling, some mild pain when lifting anything, painful to touch.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Blistery rash on side and back painful, itchy, and burning patient diagnosed w/shingles 5/9/18.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Insomnia, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). Previously administered products included SHINGRIX with an associated reaction of influenza like illness (after 1st dose the patient experienced fever, chills, flu like symptoms, insomnia and tremor (this case was linked with US2018026310 for the 2nd dose)). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 15 hrs after receiving SHINGRIX, the patient experienced fever (serious criteria disability), chills and tremor. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the chills and tremor were unknown. It was unknown if the reporter considered the fever, chills and tremor to be related to SHINGRIX. Additional information was received as follows: The patient received a dose of SHINGRIX in left arm. The event onset date was provided only as 3 AM, no date was provided. The time to onset was assumed to be 15 hours. The patient was seen at the hospital and given 2 bags of fluid. No further information was reported regarding the event.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). Previously administered products included SHINGRIX with an associated reaction of influenza like illness (after 1st dose the patient experienced fever, chills, flu like symptoms, insomnia and tremor (this case was linked with US2018026310 for the 2nd dose)). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, 15 hrs after receiving SHINGRIX, the patient experienced fever (serious criteria disability), chills and tremor. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the chills and tremor were unknown. It was unknown if the reporter considered the fever, chills and tremor to be related to SHINGRIX. Additional information was received as follows: The patient received a dose of SHINGRIX in left arm. The event onset date was provided only as 3 AM, no date was provided. The time to onset was assumed to be 15 hours. The patient was seen at the hospital and given 2 bags of fluid. No further information was reported regarding the event.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness in fingers in a 58-year-old female patient who received SHINGRIX. On 15th April 2018, the patient received SHINGRIX. On 15th April 2018, less than a day after receiving SHINGRIX, the patient experienced numbness in fingers, hypersensitivity, tingling of extremity and neuropathy. On an unknown date, the outcome of the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy were unknown. It was unknown if the reporter considered the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy to be related to SHINGRIX. Additional information was received as follows: The physician reported that the patient received a SHINGRIX and was experiencing tingling on fingers, numbness in fingers (the 2nd to 5th fingers) and on latter side of palm (all on the same side the injection  was given). The patient also hypersensitivity of nerves and possible neuropathy. These symptoms started on the day she received the vaccine and were still persisting. No further information was provided. Upon an internal review on 10th May 2018, following changes were performed: The event hypersensitivity of nerves was changed to hyperalgesia. This case was upgraded to serious because of the event neuropathy (serious criteria GSK medically significant).
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyperaesthesia, Hypersensitivity, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness in fingers in a 58-year-old female patient who received SHINGRIX. On 15th April 2018, the patient received SHINGRIX. On 15th April 2018, less than a day after receiving SHINGRIX, the patient experienced numbness in fingers, hypersensitivity, tingling of extremity and neuropathy. On an unknown date, the outcome of the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy were unknown. It was unknown if the reporter considered the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy to be related to SHINGRIX. Additional information was received as follows: The physician reported that the patient received a SHINGRIX and was experiencing tingling on fingers, numbness in fingers (the 2nd to 5th fingers) and on latter side of palm (all on the same side the injection  was given). The patient also hypersensitivity of nerves and possible neuropathy. These symptoms started on the day she received the vaccine and were still persisting. No further information was provided. Upon an internal review on 10th May 2018, following changes were performed: The event hypersensitivity of nerves was changed to hyperalgesia. This case was upgraded to serious because of the event neuropathy (serious criteria GSK medically significant).
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: Severe fatigue and sleeping 4 days, arm sore 2 days after immunization, heart palpitations starting April 22, admitted to ER on April 22 and released same day. Heart palpitations continued and re-examined on April 24 at which time a 24-hour heart monitor was placed. Arm pain continued to get worse, patient saw PCP on May 3. May 7 patient saw a different doctor concerning the arm pain and a cortisone injection was given.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations
Clinical narrative: Severe fatigue and sleeping 4 days, arm sore 2 days after immunization, heart palpitations starting April 22, admitted to ER on April 22 and released same day. Heart palpitations continued and re-examined on April 24 at which time a 24-hour heart monitor was placed. Arm pain continued to get worse, patient saw PCP on May 3. May 7 patient saw a different doctor concerning the arm pain and a cortisone injection was given.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Cardiac monitoring, Electrocardiogram normal, Fatigue, Hypersomnia
Clinical narrative: Severe fatigue and sleeping 4 days, arm sore 2 days after immunization, heart palpitations starting April 22, admitted to ER on April 22 and released same day. Heart palpitations continued and re-examined on April 24 at which time a 24-hour heart monitor was placed. Arm pain continued to get worse, patient saw PCP on May 3. May 7 patient saw a different doctor concerning the arm pain and a cortisone injection was given.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Palpitations, X-ray limb normal
Clinical narrative: Severe fatigue and sleeping 4 days, arm sore 2 days after immunization, heart palpitations starting April 22, admitted to ER on April 22 and released same day. Heart palpitations continued and re-examined on April 24 at which time a 24-hour heart monitor was placed. Arm pain continued to get worse, patient saw PCP on May 3. May 7 patient saw a different doctor concerning the arm pain and a cortisone injection was given.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 58-year-old female patient who received SHINGRIX. The patient's past medical history included splenectomy. Concurrent medical conditions included hypothyroidism and Hodgkin's disease. Concomitant products included omeprazole. On 19th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 19th April 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness (serious criteria disability and life threatening). In April 2018, the outcome of the dizziness was recovered/resolved. The reporter considered the dizziness to be possibly related to SHINGRIX. Additional information was reported as follows: The patient received PRO AIR as a concomitant medication. The pharmacist reported that, on 19th April 2018 at 5-6:00 pm the patient was vaccinated with SHINGRIX vaccine. Within 3 hours after the vaccination, the patient experienced dizziness that lasted for a period of 21 hours. During that time, the patient also reported that she couldn't do anything because of the dizziness. The patient  did suffered from other comorbidities including Hodgkin's disease, hypothyroidism and has had a splenectomy. The patient canceled her second shot because of the symptoms she experienced. She was refusing the second shot.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood culture, Blood glucose, Blood lactic acid, Full blood count, Pyrexia
Clinical narrative: Same day as vaccine, patient developed fever, seizure lasting longer than 15 minutes requiring hospital admission. Patient remains febrile despite treatment with antipyretics. Treatment is ongoing.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Seizure
Clinical narrative: Same day as vaccine, patient developed fever, seizure lasting longer than 15 minutes requiring hospital admission. Patient remains febrile despite treatment with antipyretics. Treatment is ongoing.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Diarrhoea, Nausea, Retching
Clinical narrative: Nausea, retching, diarrhea, stomach discomfort.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash generalised
Clinical narrative: Fever of about 100-102 degrees, rash/spots all over body, loss of appetite.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular, Rash vesicular, Scab, Varicella post vaccine
Clinical narrative: Child had 2 doses of VARIVAX  07/12/2014 and 08/08/2017. On 05/08/2018- child was seen in office with mild case of varicella- 20-25 pox on trunk and bilateral thighs, 3 crusted, most vesicular, 3-5 new.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 10-APR-2018, the patient was vaccinated with one dose of expired VAQTA intramuscularly, lot number N01234, expiration date 05-APR-2018 (exact dose was not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date, the patient was inadvertently administered an incomplete dose of M-M-R II, (lot number N027782, expiry date: 16-AUG-2019) subcutaneously for prophylaxis due to patient moving arm (underdose). No adverse effects reported. No product quality complaint involved.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018, the patient was vaccinated with PROQUAD (lot number M031565; expiry date: 24-DEC-2017) for prophylaxis (expired product administered). The sterile diluent which was used for reconstitution of the vaccine was properly stored. No adverse effects were reported. The reporter confirmed that the expired PROQUAD had no temperature excursions prior to being administered. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Therapy non-responder
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an 8 year old female patient. No pertinent medical history, drug reactions/allergies nor concomitant medications were reported. On an unspecified date approximately in 2011 (reported as "when she was one year old") and then in approximately 2015 (also reported as "when she was 5 years old") the patient was vaccinated with the first and second doses of M-M-R II respectively (Lot number, expiration dates, dosage and route of administration were not provided) for vaccination. On an unknown date (reported as recently), the patient had titers drawn and showed no immunity to M-M-R II (therapy non-responder). The reporter stated that it might be possible that the physician who administered the M-M-R II doses to the patient might have given less than the recommended dose, only "a half or a third of the dose" (underdose). At the time of reporting, the outcome of therapy non-responder and underdose was unknown. The reporter did not assess the causal relationship between the adverse events and the vaccination with M-M-R II.
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Pyrexia
Clinical narrative: This social media spontaneous report was received from a physician, via a company representative through a post from the patient's mother, referring to an approximately 1 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown by reporter. Concurrently, the patient had a total anomalous pulmonary venous return. On 27-APR-2018, reported as "8 days ago", the patient was vaccinated with M-M-R II for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). On 05-MAY-2018, the boy had a high fever of 103 (units not provided) (pyrexia) and his hands and mouth turned blueish (cyanosis). Medical attention was sought but the reporter did not know if the patient received any treatment or if any laboratory study was performed. At the reporting time, the outcome of cyanosis and pyrexia was unknown. The causality assessment between the aforementioned adverse events and M-M-R II was not provided.
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced unspecified adverse effects (adverse event). At the time of reporting, the outcome of the event was unknown. The causality assessment between the event and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, intramuscular injection, lot number N030849 and expiration date on 09-JUN-2019, for prophylaxis (dose and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of 47.1 degrees Fahrenheit for 1 hour, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On 16-AUG-2016, the patient received the first dose of GARDASIL 9, on 17-NOV-2017, the patient received the second dose of GARDASIL 9, and on 12-JAN-2018, the patient received the third dose of GARDASIL 9 all the vaccines were administered intramuscularly and the indication was prophylaxis (lot number and expiration date were not informed). No adverse effects were reported.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Joint swelling, Myalgia
Clinical narrative: PT. DEVELOPED SWELLING, REDNES AND PAIN  AT BOTH RIGHT AND LEFT THIGH RADIATING TO GLUTEAL AREA.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Swelling
Clinical narrative: PT. DEVELOPED SWELLING, REDNES AND PAIN  AT BOTH RIGHT AND LEFT THIGH RADIATING TO GLUTEAL AREA.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV1, MMR, MNQ, TDAP, TYP
Symptoms: Mass, Rash, Tenderness, Urticaria
Clinical narrative: Patient reported hive-like rash on back of neck on 4/27/2018. She presented to pharmacy on 5/10/2018 with a half-dollar sized lump on her forehead that was tender to the touch. Patient said that the lump had reduced in size since earlier in the morning. Patient was instructed to take diphenhydramine if lump began to itch and to see doctor if the rash spread or if systemic symptoms began.