chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Malaise, Nausea, Pallor, Urinary incontinence
Clinical narrative: Approximately 9 hours after vaccination, mild to moderate generalized symptom of not feeling well for 1/2 hour followed by sudden and rapid onset of perfuse sweating, feeling weak and off balance, and generalized symptom of feeling very poor. Husband and 6 friends were present and said that my facial color quickly disappeared. I felt nauseous and was helped to the bathroom as I felt too weak to walk and I vomited the dinner I had just eaten. At the same time I lost temporary control of my bladder and anal sphincter. I went home and immediately went to bed. I did not have any other episodes of vomiting or diarrhea. I felt weak in the morning but felt back to almost normal (90%) after breakfast and hot tea. I had normal bowel movements the next day and urine was clear.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Approximately 9 hours after vaccination, mild to moderate generalized symptom of not feeling well for 1/2 hour followed by sudden and rapid onset of perfuse sweating, feeling weak and off balance, and generalized symptom of feeling very poor. Husband and 6 friends were present and said that my facial color quickly disappeared. I felt nauseous and was helped to the bathroom as I felt too weak to walk and I vomited the dinner I had just eaten. At the same time I lost temporary control of my bladder and anal sphincter. I went home and immediately went to bed. I did not have any other episodes of vomiting or diarrhea. I felt weak in the morning but felt back to almost normal (90%) after breakfast and hot tea. I had normal bowel movements the next day and urine was clear.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patients states he has difficulty raising his arm above his head and also holding his arm out in front of him. He has tried ALEVE, warm compress, cold compress, ASPERCREME, BIOFREEZE and massaging. It has continued to give him pain ever since the injection date (20 days). Patient was advised to seek out his PCP.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: REDNESS AROUND SITE OF INJECTION.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Patient was administered flu vaccine in right deltoid muscle of the upper arm. Patient informed Pharmacist 12 days later that he was experiencing pain at the injection site. Pain felt like a knot at the injection site; over time pain improved but moved to front side of arm in bicep. Patient massaged injection site after administration. There was no bruising or bleeding per patient. Advised patient to monitor and if pain does not go away or improve to seek medical attention. Informed primary care physician.
Age: 28.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient came in for her 2nd dose of Hepatitis B and A. Hepatitis B was given first followed by Hepatitis A. The vaccine was given at 11:45 am and after the Hepatitis A vaccine, the patient fainted and leaned her head to the right for 2 second and woke up. I immediately gave her 2 glucose tablets and 1 cup of water. I offered to call 911 but she states that she is better and refused to call 911. I requested that she sit there until she is all better. She sat for about 10 minutes and stood up wanting to walk around. I gave her the jar of glucose tablet to bring with her and advised that she come check in with me before leaving the store. She said that she is better and that she will not leave the store until she can drive again.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Patient felt headache, Body ache and tiredness. After one day she had Rash and red hard bump at inject site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient felt headache, Body ache and tiredness. After one day she had Rash and red hard bump at inject site.
Age: 81.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Patient reports severe pain in arm where shot was given, especially when moving arm. It is 18 days since she received the shot and this is the first reporting of it. She said it started immediately after the shot, though she did not mention it at the time. She says the area looks fine, no swelling or redness.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Patient developed uticaria on anterior neck, upper chest, back, and upper arms. Uticaria developed one day after vaccine administration (02/05/2018) and persisted through 02/10/2018 when he was sent to the emergency room. No fever, difficulty breathing, swollen airway noticed or complained of.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain and tenderness at injection site. Could not lift left arm!
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient developed redness and skin became hard to the touch surrounding injection site about 2 hours after immunization was given. She developed chills later on at night and her arm was still swollen and sore for a few days after the injection.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient developed uticaria surrounding injection site that spread down his arm ending in the upper forearm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased
Clinical narrative: 2/9 night: Left arm pain. Chills/cold feeling, went to bed around 9pm. Awoke at 3am sweating, shaking/weak. Thinking she had low blood sugar the patient attempted to eat a cookie but felt too nauseous so she only ate a few bites and went back to bed. 2/10 morning: Still felt weak upon awakening. Blood sugar reading 216mg/dL at 6am, patient reports it is normally around 150mg/dL. 2/10 afternoon: She felt lethargic all day and started to experience pain near the armpit around 4pm. At this time the pain near the injection site was less severe than 2/9 night. Upon examination, patient noticed a red, raised rash spanning from the top of the left arm to the mid-upper arm below the deltoid. 2/11 morning: Feels less lethargic, blood sugar back to normal range. Rash still present, only mild pain. Called the pharmacy to report event 11:30am 2/11.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The day after the injection the patient reported that his left arm is numb and tingly and also his right thumb is numb. He says that it comes and goes.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Altered state of consciousness, Hyperhidrosis, Malaise, Swelling, Tenderness
Clinical narrative: Hot swollen and tender on evening of the immunization. Next morning feeling sick to stomach and sweaty and feeling like passing out.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Muscular weakness
Clinical narrative: Flu Vaccine Oct 2017, symptoms of progressive leg weakness began less than 1 week later. Currently diagnosed and treated for CIDP.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient states she had extreme muscle pains from head to toe but injection site itself was ok. Pain lasted for few days.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Patient received pneumonia vaccination on 01/27/2018 and she stated that she experience shortness of breath and chest pain on 01/28/2018. Patient went to ER on 1/29/2018 and was diagnosed with precordial pain. ER doctor recommended patient to see PCP to check lab work on metabolic panel, iron and folic acid level. Patient is planning to go to urgent care again on today 2/11/18.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 01-Feb-2018, concerning a female patient of unspecified age. The patient's current condition included egg allergy. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, manufacturer, batch number and expiry date: unknown). On an unspecified date, after the vaccination, the patient had trouble in breathing and her throat was closed. The patient received EPIPEN and an unknown treatment. The patient had undergone an allergy test, at the time of these events. The reporter assessed the events (trouble in breathing and throat constriction) as related to suspect vaccine. The subject had recovered from the events.
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Tingling in legs and arms; This is a spontaneous case initially received from other non-health professional (reference number SEQ18-0873) on 11-Feb-2018, concerning a female patient of unspecified age.  The patient's current condition included diabetes. The patient's concomitant medications were not reported.   On an unknown date, reported as 20 or 30 years ago, the patient was administered unspecified Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date: not reported) for an unknown indication.  On an unspecified date, an unknown amount of time after vaccination, the patient experienced tingling in legs and arms.  The outcome of the event was not reported.   This case was linked to report 201800451 (same reporter).  Follow up retrieved from VAERS (VAERS ID: 742250-1) reported to VAERS by non-health professional on 02-Jul-2018: VAERS ID was updated. Upon internal review, it was relaised that listedness of the event tingling was incorrect, hence it was corrected (unlisted to listed in flu vaccine cell subunit NVD and flu vaccine Egg split. Amended narrative accordingly.  Follow-up reported by other non-health professional [reference number: SEQ19-05971] on 31-Oct-2019: Patient's medical history added. Company causality updated to related. Additional reference number added. Narrative was amended accordingly.  Company Comment: The event of paraesthesia of limbs is considered related to Flu vaccine.; Sender's Comments: The event of paraesthesia of limbs is considered related to Flu vaccine.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Apparent death, Coma, Hernia repair, Pancreatitis, Respiratory failure
Clinical narrative: Initial unsolicited report received from consumer via other company GSK (manufacturer report number: US2017003102) on 02-Feb-2018. This case involves a female patient (age was not reported) who was vaccinated with an injection of INFLUENZA VACCINE (form: injection, solution, batch number, expiry date was not reported, route and site of administration were unknown), a dose of PREDNISONE (batch number, expiry date was not reported, route and site of administration were unknown), a dose of VENTOLIN (batch number: 9E6S, expiry date: 31-Jan-2018, route and site of administration were unknown) on 08-Oct-2016. Patient also received a dose of COMBIVENT (batch number, expiry date was not reported, route and site of administration were unknown) on an unknown date. The patient was a smoker/ tobacco user (quitted smoking 5 years before reporting date), cold, Crohn's and Crohn's surgery. Concomitant medication included SPIRIVA. On an unknown date, post vaccination, the patient experienced pulmonary failure. On 02-Nov-2016, the patient was hospitalized and was diagnosed with pancreatitis. On an unknown date, following the vaccination, the patient went into coma and almost died (near death experience). On an unknown date, following the vaccination, the surgery was performed to repair hernia. Patient previously received INFLUENZA VACCINE (batch number, expiry date was not reported, route and site of administration were unknown) on an unknown date in 2011 and experienced Hospitalization. Laboratory investigations were not reported. Corrective treatment includes surgery to repair hernia and was on oxygen full time and only had 8 to 10 percent lung capacity. The outcome of the events was not reported. It was also reported that the patient was discharged from the hospital on 18-Nov-2016. This case was reported as serious due to medically significant events. The case was also considered as serious due to life threatening event near death experience. List of documents held by sender: none. Sender's Comments: The time to onset was compatible. The patient's medical history was reported as used to being a smoker, condition at the time of vaccination was not reported. The patient was on medications that suggested preexisting respiratory condition that should be investigated. The patient already had cold when she was administered influenza vaccine. The possibility of the events being related to a preexisting etiology seem to be high in this case. Additional information regarding patient's medical history, condition at the time of vaccination, lab tests and etiological work up ruling out underlying infectious etiologies is necessary to assess the causal relationship with respect to the vaccine. Based upon reported information the role of the vaccine cannot be assessed.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of legs in a adult male patient who received SHINGRIX (batch number 9XC39, expiry date unknown). On 4th December 2017, the patient received SHINGRIX. On 4th December 2017, several hours after receiving SHINGRIX, the patient experienced swelling of legs, feeling unwell, general body pain, headache, fever, chills, rash, sores mouth and fatigue. On an unknown date, the outcome of the swelling of legs, feeling unwell, general body pain, headache, fever, chills, rash, sores mouth and fatigue were unknown. It was unknown if the reporter considered the swelling of legs, feeling unwell, general body pain, headache, fever, chills, rash, sores mouth and fatigue to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the Licensed practical nurse (LPN). The age at vaccination was not reported. On 4th December at 11 am the patient was vaccinated with SHINGRIX and that evening started feeling sick with body aches, headache, fever, chills, leg swelling, rash on chest and legs, sores in mouth and fatigue.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rash, Stomatitis
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of legs in a adult male patient who received SHINGRIX (batch number 9XC39, expiry date unknown). On 4th December 2017, the patient received SHINGRIX. On 4th December 2017, several hours after receiving SHINGRIX, the patient experienced swelling of legs, feeling unwell, general body pain, headache, fever, chills, rash, sores mouth and fatigue. On an unknown date, the outcome of the swelling of legs, feeling unwell, general body pain, headache, fever, chills, rash, sores mouth and fatigue were unknown. It was unknown if the reporter considered the swelling of legs, feeling unwell, general body pain, headache, fever, chills, rash, sores mouth and fatigue to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the Licensed practical nurse (LPN). The age at vaccination was not reported. On 4th December at 11 am the patient was vaccinated with SHINGRIX and that evening started feeling sick with body aches, headache, fever, chills, leg swelling, rash on chest and legs, sores in mouth and fatigue.
Age: 66.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient's husband stopped by the pharmacy around 6 weeks post-vaccination and asked if anyone else had complained of symptoms from the flu shot. He described his wife's pain as severe and said she could not sleep at night or move/lift her arm due to the pain since she had her shot. She had an appointment with the doctor, but the 2 pharmacists on duty recommended OTC pain relievers and warm/cold compresses. We called a week or so later and she was still having the same symptoms. She stated her doctor recommended physical therapy and she hadn't started yet because she had been sick. We are waiting to hear about from her to see how her therapy went.
Age: 66.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Patient's husband stopped by the pharmacy around 6 weeks post-vaccination and asked if anyone else had complained of symptoms from the flu shot. He described his wife's pain as severe and said she could not sleep at night or move/lift her arm due to the pain since she had her shot. She had an appointment with the doctor, but the 2 pharmacists on duty recommended OTC pain relievers and warm/cold compresses. We called a week or so later and she was still having the same symptoms. She stated her doctor recommended physical therapy and she hadn't started yet because she had been sick. We are waiting to hear about from her to see how her therapy went.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Delivery, Exposure during pregnancy, Neonatal disorder
Clinical narrative: This prospective pregnancy report was received from a registered nurse referring to a 28 year old female patient who was currently pregnant (27 weeks). Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 28-SEP-2016, the patient was inadvertently vaccinated with GARDASIL 9 lot # M016193, 0.5 ml, intramuscular for prophylaxis while the patient was 27 weeks of pregnant. The patient's last menstrual period could be estimated as 23-MAR-2016, date of estimated delivery date could be estimated 28-DEC-2016 and date of conception date was not provided. No adverse event was reported. No further information was provided. Additional information has been requested. Follow-up was received from nurse on 29-JAN-2018. It was reported that the patient was doing fine after her pregnancy. She gave birth to a son on 21-DEC-2016. The child had supraventricular (SV) tachycardia at birth and had been hospitalized 8 times in the past year for the SV tach (captured in MARRS# 1802USA000318). She reported that the child was otherwise healthy and had not been diagnosed with any congenital anomaly or anything other than SV tach. No further information is available. This case was cross referenced with the baby case 1802USA000318. Sender's Comments: US-009507513-1802USA000318.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 33 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 24-JAN-2018, the patient was vaccinated with VARIVAX from lot N019133 expiry date 22-JUN-2019 for prophylaxis.  Other suspect therapies included sterile diluent (DILUENT MRK INJ) from lot N021894 expiry date 28-NOV-2019. Pharmacist reported that the patient returned to the pharmacy on 07-FEB-2018 with "a red (injection site erythema), warm area at the injection site (injection site warmth) and 2 'spots'; one on her back and one on her chest, resembling insect bites (Dermatitis allergic) which she experienced on 06-FEB-2018. No fever or other symptoms reported. Pharmacist refused VZVIP Packet. The outcome of injection site erythema, Dermatitis allergic and injection site warmth was reported as not recovered. Causality assessment was not provided. No additional information provided.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis allergic, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 33 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 24-JAN-2018, the patient was vaccinated with VARIVAX from lot N019133 expiry date 22-JUN-2019 for prophylaxis.  Other suspect therapies included sterile diluent (DILUENT MRK INJ) from lot N021894 expiry date 28-NOV-2019. Pharmacist reported that the patient returned to the pharmacy on 07-FEB-2018 with "a red (injection site erythema), warm area at the injection site (injection site warmth) and 2 'spots'; one on her back and one on her chest, resembling insect bites (Dermatitis allergic) which she experienced on 06-FEB-2018. No fever or other symptoms reported. Pharmacist refused VZVIP Packet. The outcome of injection site erythema, Dermatitis allergic and injection site warmth was reported as not recovered. Causality assessment was not provided. No additional information provided.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Full blood count normal, Influenza virus test negative, Pyrexia, Rash generalised
Clinical narrative: Two days after vaccination the child developed a high persistent fever (104°F). On the third the child had convulsions due to the fever and on the fifth day he developed rash through his whole body.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Seizure, Stool analysis normal, Urine analysis normal
Clinical narrative: Two days after vaccination the child developed a high persistent fever (104°F). On the third the child had convulsions due to the fever and on the fifth day he developed rash through his whole body.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Influenza virus test negative, Pyrexia, Rash generalised, Seizure
Clinical narrative: Two days after vaccination the child developed a high persistent fever (104°F). On the third the child had convulsions due to the fever and on the fifth day he developed rash through his whole body.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Stool analysis normal, Urine analysis normal, White blood cell count normal
Clinical narrative: Two days after vaccination the child developed a high persistent fever (104°F). On the third the child had convulsions due to the fever and on the fifth day he developed rash through his whole body.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pain in extremity, Poor quality sleep, Quality of life decreased
Clinical narrative: My left arm has severe and debilitating pain. Starting within a couple hours after shot. It is now going on 12 weeks since the injection. The pain keeps me awake at night and has taken much joy from my life.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Adverse effect to anthrax vaccination. Pt received anthrax vaccination 30 Jan & approximately 15 hours later developed RUE edema and TTP from injection site just below shoulder to elbow. The immunization was given by an immunizations back up technician. The pt was administered IM .5 ml into the R deltoid per protocol. Was seen 2 Feb 18 at 1:40 pm at the Clinic. Skin was taut and warm to touch. No erythema or streaking. The provider discussed conservative treatment with patient. Recommend ice, elevation, Ibuprofen and rest. Follow up in one week if symptoms persist or sooner as needed. Since pt has received vaccine in the past with no issues, do not recommend permanent exemption at this time. Pt may receive next vaccination when it is due and if he responds the same way, may consider permanent exemption.
Age: 42.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Arthralgia, Discomfort, Erythema, Gait disturbance, Joint range of motion decreased
Clinical narrative: NOTICED SHOULDER REDNESS AND SORENESS FOR OVER 1 WEEK FROM TIME OF RECEIVING SHOT FOR TWINRIX. Jan 25th, started to feel achy and stiff knees. Jan 26th, wrists and elbows started to feel sore and achy - started to take ALEVE to relieve from pain. By Jan 28 toes, ankles, knees, elbows, wrists and fingers were extremely stiff and extreme pain and discomfort. Feet and hands began to swell - feet showed signs of redness and became extremely and uncontrollably itchy. Used ice packs and ALEVE for relief. By Jan 30th, itchiness, swelling of hands and feet continued, extreme joint stiffness could barely stand up and walk across the room. Began researching "post vaccinal arthritis". Feb 1 - flight exacerbated swelling of hands and feet. Notified doctor of symptoms - suggested to take ADVIL. Feb 2 - iced swollen hands and feet for hours at a time and took ADVIL (3 pills every 6 hours) - extreme. Notified Health Clinic - responded response on Feb 5th by FNP, BC, Clinic Operations of Health stating that the symptoms I was experiencing were abnormal and "Systemic symptoms involving the joints are not typical following vaccine administration and to seek immediate medical care". Feb 5th - noticed some improvement in stiffness and itchiness of feet - felt a slight bit more mobility in joints, took ADVIL, drinking Fiji water (silica mineral water), ginger/garlic supplements for inflammation. Feb 8th - further improvement in mobililty, swelling reduced in feet, hands still extremely stiff and achy in knuckle joints. Feb12 -significant improvement - some discomfort in hands, all other joints improved.
Age: 42.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Joint stiffness, Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: NOTICED SHOULDER REDNESS AND SORENESS FOR OVER 1 WEEK FROM TIME OF RECEIVING SHOT FOR TWINRIX. Jan 25th, started to feel achy and stiff knees. Jan 26th, wrists and elbows started to feel sore and achy - started to take ALEVE to relieve from pain. By Jan 28 toes, ankles, knees, elbows, wrists and fingers were extremely stiff and extreme pain and discomfort. Feet and hands began to swell - feet showed signs of redness and became extremely and uncontrollably itchy. Used ice packs and ALEVE for relief. By Jan 30th, itchiness, swelling of hands and feet continued, extreme joint stiffness could barely stand up and walk across the room. Began researching "post vaccinal arthritis". Feb 1 - flight exacerbated swelling of hands and feet. Notified doctor of symptoms - suggested to take ADVIL. Feb 2 - iced swollen hands and feet for hours at a time and took ADVIL (3 pills every 6 hours) - extreme. Notified Health Clinic - responded response on Feb 5th by FNP, BC, Clinic Operations of Health stating that the symptoms I was experiencing were abnormal and "Systemic symptoms involving the joints are not typical following vaccine administration and to seek immediate medical care". Feb 5th - noticed some improvement in stiffness and itchiness of feet - felt a slight bit more mobility in joints, took ADVIL, drinking Fiji water (silica mineral water), ginger/garlic supplements for inflammation. Feb 8th - further improvement in mobililty, swelling reduced in feet, hands still extremely stiff and achy in knuckle joints. Feb12 -significant improvement - some discomfort in hands, all other joints improved.
Age: 42.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Pruritus
Clinical narrative: NOTICED SHOULDER REDNESS AND SORENESS FOR OVER 1 WEEK FROM TIME OF RECEIVING SHOT FOR TWINRIX. Jan 25th, started to feel achy and stiff knees. Jan 26th, wrists and elbows started to feel sore and achy - started to take ALEVE to relieve from pain. By Jan 28 toes, ankles, knees, elbows, wrists and fingers were extremely stiff and extreme pain and discomfort. Feet and hands began to swell - feet showed signs of redness and became extremely and uncontrollably itchy. Used ice packs and ALEVE for relief. By Jan 30th, itchiness, swelling of hands and feet continued, extreme joint stiffness could barely stand up and walk across the room. Began researching "post vaccinal arthritis". Feb 1 - flight exacerbated swelling of hands and feet. Notified doctor of symptoms - suggested to take ADVIL. Feb 2 - iced swollen hands and feet for hours at a time and took ADVIL (3 pills every 6 hours) - extreme. Notified Health Clinic - responded response on Feb 5th by FNP, BC, Clinic Operations of Health stating that the symptoms I was experiencing were abnormal and "Systemic symptoms involving the joints are not typical following vaccine administration and to seek immediate medical care". Feb 5th - noticed some improvement in stiffness and itchiness of feet - felt a slight bit more mobility in joints, took ADVIL, drinking Fiji water (silica mineral water), ginger/garlic supplements for inflammation. Feb 8th - further improvement in mobililty, swelling reduced in feet, hands still extremely stiff and achy in knuckle joints. Feb12 -significant improvement - some discomfort in hands, all other joints improved.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Pruritus generalised, Vaccination site pain
Clinical narrative: It started as itching in the right arm, then the left arm and back and then the whole body. The patient also reported pain at the site of the vaccines administration.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly storage dose of PROQUAD, lot # N023967, expiration date 28-FEB-2019, (dose number, dose, and route were not reported), for prophylaxis. Other suspect therapies included sterile diluent (MERCK), (Lot number N027626 Expiration date 20-MAY-2019). The PROQUAD and the sterile diluent (MERCK) was on a temperature excursion from 6 to 14 Fahrenheit Degrees during 1 hour and 18 minutes; and from 15 to 46 Fahrenheit Degrees during 34 hours and 29 minutes. Both products had multiple previous temperature excursions. The digital data logger was involved. No adverse effects or reactions had been reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1802USA004732, US-009507513-1802USA004733, US-009507513-1802USA004734, US-009507513-1802USA004735, US-009507513-1802USA004736, US-009507513-1802USA004737, US-009507513-1802USA004738, US-009507513-1802USA004739, US-009507513-1802USA004740, US-009507513-1802USA004741, US-009507513-1802USA004742, US-009507513-1802USA004743, US-009507513-1802USA004744, US-009507513-1802USA004745, US-009507513-1802USA004746, US-009507513-1802USA004747, US-009507513-1802USA004748, US-009507513-1802USA004749, US-009507513-1802USA004750, US-009507513-1802USA004751, US-009507513-1802USA004752, US-009507513-1802USA004753, US-009507513-1802USA004754, US-009507513-1802USA004755, US-009507513-1802USA004756, US-009507513-1802USA004757.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of (Oka/Merck) VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees F for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees F for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1802USA004551: US-009507513-1802USA004550: US-009507513-1802USA004552.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Malaise, Product storage error
Clinical narrative: This spontaneous report was received from an unspecified health professional and refers to a 4 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-NOV-2017, the patient was vaccinated with an improperly stored dose number 1 of PROQUAD lot # M043307, expiration date 24-APR-2018, by subcutaneous route in the left thigh for prophylaxis. Previous temperature excursions were detected and the digital data logger was involved (product storage error). Additionally it was reported that the patient did not have any illness at the time of vaccination and no other vaccinations were administered within 4 weeks prior to this date. On 13-NOV-2017, reported by the patient's mother, he got sick following vaccination (malaise). This event was reported to an unspecified doctor and the patient recovered from the event on an unknown date. The reporter did not assess the causal relationship between therapy with PROQUAD and the aforementioned event. This is one of several reports received from the same reporter (MARRS # 1712USA003118); Sender's Comments: US-009507513-1712USA003118.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a currently 15 years old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-JUL-2015, the patient received a dose of GARDASIL Lot number K006191 for prophylaxis (dose, route of administration, anatomical location and expiration date were not reported). On an unspecified date in 2017, the patient received a dose of GARDASIL 9 Lot number N001533, expiration date 16-OCT-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). However, no adverse effects were reported.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Tongue disorder
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 46 year old female patient. The patient had a known allergy to penicillin. The patient had no pertinent medical history or concurrent conditions. The patient's concomitant therapies included vitamin D3, folic acid and unspecified multivitamins. On 08-JAN-2018, the patient was vaccinated with the 1st dose of varicella (Oka/Merck) VARIVAX, subcutaneously (lot # and expiration date were not provided) for prophylaxis. On 10-JAN-2018, the patient developed red, raised bumps on her chest, back and side (rash erythematous). Furthermore, the patient developed 2 bumps on the inside of her tongue following (tongue disorder). The patient sought for medical attention, however no treatment was provided for her symptoms. No laboratory diagnostic procedures were performed. At the time of the report, the outcome of tongue disorder and rash erythematous was reported as not recovered. Additionally, a causality between the adverse events and vaccination with Oka/Merck VARIVAX was not provided.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with the 1st dose of GARDASIL (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. The nurse reported, that the patient might receive a second dose of GARDASIL 9 to complete the series that was started with GARDASIL. No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 13 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of Wistar ra 27-3 M-M-R II (dose, therapy type, Lot # and expiration date not reported) for prophylaxis. Concomitant therapy included the diluent (dose, Lot #, expiration date not provided). On an unknown date, 5 months after the first dose, the patient received the second dose of Wistar ra 27-3 M-M-R II. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old diabetic female patient with no drug reaction or allergies. On 22-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular in unspecified arm for prophylaxis (dose, lot # and expiration date were not reported). There was no concomitant therapy. On 22-JAN-2018, injection site pain, injection site erythema and injection site swelling; and a red band wrapping around the (unspecified) arm below injection site (erythema). The patient sought medical attention by returned to the pharmacy. No treatment was given. No laboratory diagnostic tests were performed. The outcome of erythema, injection site swelling, injection site erythema and injection site pain was reported as not recovered. The relationship between events and PNEUMOVAX23 was not reported.
Sex: M
Vaccine: FLUX, HEP
Symptoms: Muscle tightness, Musculoskeletal pain, Nausea, Nocturia
Clinical narrative: This spontaneous report was received from the patient's girlfriend concerning her boyfriend of unknown age. The patient's pertinent medical history, drug allergies/drug reactions were not reported. On 23-JAN-2018, the patient was vaccinated with a third dose (final dose) of hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, Lot #, expiration date and therapy type not reported) for prophylaxis. Concomitant vaccine given on the same day included influenza virus vaccine (unspecified) and paroxetine hydrochloride (PAXIL) which started that evening of 23-JAN-2018.     The patient's girlfriend reported that on 25-JAN-2018, reported as yesterday, he complained of increased urination overnight and slight nausea, and on 26-JAN-2018, reported as this afternoon, he complained of severe tension/pain in his shoulders.   The outcome of nocturia, muscle tightness, musculoskeletal pain and nausea was unknown.        The causal relationship between the events and hepatitis b vaccine (recombinant) (manufacturer unknown) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JAN-2018, the patient was vaccinated with a dose of improperly stored Oka/Merck VARIVAX lot number N001527, expiration date 13-JAN-2019 for prophylaxis (frequency and route of administration were not reported). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored. On unknown dates, the doses of Oka/Merck VARIVAX underwent temperature excursions of 6 degrees F to 14 degrees F for 69 hours 2 minutes, 15 degrees F to 46 degrees F for 36 hours 14 minutes. A previous temperature excursion of 15 degrees F to 46 degrees F for 60 hours was reported. Temperature excursions were detected by the data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1801USA010690: US-009507513-1802USA004842: US-009507513-1802USA004843.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the husband of a 79 year old female patient, concerning his wife. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patient received 2 injections of PNEUMOVAX 23 in the arm, "9 months apart" at the recommendation of her physician (dose, route of administration, lot number and expiry date were not provided). No adverse event was reported.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a 34, year old female patient, who was also a licensed practical nurse, concerning herself. The patient's current conditions included allergy to shellfish. Concomitant medications included ZYRTEC. The patient had no pertinent medical history. The nurse reported she received two doses of (Wistar ra 27-3) virus vaccine, live HSA M-M-R II. The first (Wistar ra 27-3) virus vaccine, live HSA M-M-R II was administered for prophylaxis on 28-OCT-1983, and the second (Wistar ra 27-3) virus vaccine, live HSA M-M-R II was administered also for prophylaxis on 13-FEB-2001 (lot number and expiration date were not reported for any of the aforementioned doses). On 27-JAN-2017, the patient had titers drawn, to verify immunity for nursing school, and the result showed low titers for Mumps and Rubella. At the time of this report, it was unknown if the patient recovered from the events. Causality assessment was not provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: This spontaneous report was received from a consumer refers to an approximately 65 year old male patient, concerning himself. The patient had no medical history, concurrent conditions or drug reactions/allergies. The patient was taking unspecified medication for blood pressure. In approximately 2017 (reported as "approximately one year ago"), the patient was vaccinated with ZOSTAVAX for shingles prevention. The vaccine was reconstituted with MERCK STERILE DILUENT (reported as "DILUENT")(dose, route of administration, frequency, lot number and expiration date were not provided). In approximately October 2017 (reported as "3 months ago") the patient started noticing that he was experiencing "blurry vision." Patient said for example when he watched television that sometimes his vision becomes blurry. The patient did not receive treatment for the event. At the time of this report, he had not recovered from the event. The patient did not seek medical attention. Causality assessment 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 and refers to an unspecified number of patients of unknown ages and genders (reported as "two or three"). The patients' concurrent conditions and medical histories were not reported. On unspecified dates in January 2018 (reported as "since 26-JAN-2018"), the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # N024385, expiration date 18-MAY-2019 (doses, routes and frequencies were not reported) for prophylaxis. It was reported that the improperly stored PNEUMOVAX23 were stored at a temperature below 32 Fahrenheit degrees (F) (average temperature of 29 F) during 9 hours. There were no previous temperature excursions. The report was due to a digital data logger. No adverse effects reported. No product quality complaint (PQC) was involved.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 16 month old female patient. The patient's medical history include scabies. Information regarding drug reactions or allergies and concurrent conditions was not reported. There were no concomitant medications. On 10-NOV-2017, the patient during her follow up visit to the clinic was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # M034189, intramuscular (strength, dose, expiration date and anatomical location were not provided), pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported) and PEDIARIX (dose, route of administration, anatomical location, lot number and expiration date were not reported) all three vaccines for prophylaxis. It was reported that the clinic refrigerator had a temperature excursion on 07-NOV2017 and 08-NOV-2017 between 39 and 48 Fahrenheit degrees (°F) and on 10-NOV-2017 was between 39 and 44 °F, for un unknown period of time, reported as "short lived excursions" and it was possibly as a result of a reading from the Digital Data Logger. However no adverse reaction and no complications were reported. Additionally it was reported that this adverse event was previously reported to the state representative on 22-DEC-2017 and to the manufacturer on 04-JAN-2017.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On 25-JAN-2018, the patient was vaccinated with a improperly stored dose of Oka/Merck VARIVAX lot # M008171, expiration date 16-FEB-2018, for prophylaxis (route of administration and dosage information were not informed). Concomitant therapies included MERCK STERILE DILUENT. No adverse effects reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1802USA004853.
Sex: U
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Information has been received from the authors in a published literature article. This case concerns a retrospective analysis that studied the impact of 7-valent pneumococcal conjugate vaccine (PCV7) on the incidence of invasive pneumococcal disease (IPD) in cancer patients, along 20 years. The patients included were registered with =1 visit(s) between 01-JAN-1992, and 31-DEC-2012. Unique patient-visits (UPV) (inpatient or outpatient) per calendar year, age, and cancer type were obtained from hospital databases. However, non-cancer patients were also included. Patients <15 years were considered "children," and =15 years were "adults." Children 04 years were referred to as "vaccinees," and patients =5 years were "non-vaccinees."  Three IPD cases "before 7-valent pneumococcal conjugate vaccine (PCV7)" had documented vaccination with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) prior to IPD diagnosis. IPD was caused by pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) serogroups (serogroup 6 in 1 patient and serogroup 15 in 2 patients). No patient's identifiers were provided. The outcome of pneumococcal infection was unknown. Upon internal review the event pneumococcal infection was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N029303 and expiration date 21-APR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). On an unknown date following the administration, the patient developed cellulitis. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse event or if lab diagnostics or studies were performed. The outcome of the event cellulitis and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. Upon internal review, cellulitis was considered to be medically significant. This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1802USA002517: US-009507513-1802USA002516: