chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 31-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Blindness cortical, Brain injury, Cardiac arrest, Cardio-respiratory arrest, Cortical visual impairment
Clinical narrative: This initial spontaneous report was received via an online news article. The article described an infant who suffered a severe reaction to the MMR vaccine (manufacturer not specified). The infant was a one year old healthy baby girl who was already walking and climbing. On 13-FEB-2013, she received vaccinations for MMR (manufacturer not specified), hepatitis A (manufacturer not specified), Hib (manufacturer not specified), PREVNAR, and varicella (manufacturer not specified).  That evening, the mother noticed the baby was irritable and feverish. After a call to the doctor, the mother was advised to give the baby TYLENOL and BENADRYL. The fever continued for several days and on the evening before the baby's scheduled pediatrician visit (exact date not specified but considered to be in 2013), the baby began having seizures. She was rushed to the Emergency Room (ER) where she went into cardiac and respiratory arrest and doctors placed her on a ventilator. The seizures and cardiac arrest left the baby with severe brain injury, encephalopathy, cortical vision impairment, truncal hypotonia, and kidney failure. After months of treatment at the hospital, she finally went home but her disabilities require specialized medical care and supervision around the clock for the rest of her life. The settlement would pay for the baby's constant high-level medical care for the rest of her life. The author of the article went on to say that the government and "Big Pharma" consistently tell the public that vaccines are safe and effective.  However, "the fact that vaccines kill and injure people, including young babies and infants, is not a fact that is in dispute". The outcome of cardiac and respiratory arrest was considered resolved. It was unknown whether the irritability, fevers, and seizures continued. The outcome of severe brain injury, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered not resolved as the patient required specialized medical care and supervision around the clock for the rest of her life. Causality assessment was considered related to MMR for all events. Causality assessment was not specifically stated for the other vaccines. Brain injury, seizures, cardiac arrest, respiratory arrest, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered disabling as the baby now required medical care around the clock for the rest of her life. Upon internal review, brain injury, cardiac arrest, respiratory arrest, seizures, encephalopathy, cortical vision impairment, and renal failure were considered to be medically significant. This is one of two reports from the same reporter (see case # 1509USA014655 discussing autism in boys in the same article). Additional information is not expected as there was no contact information.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Disability, Encephalopathy, Hypotonia, Irritability, Loss of personal independence in daily activities
Clinical narrative: This initial spontaneous report was received via an online news article. The article described an infant who suffered a severe reaction to the MMR vaccine (manufacturer not specified). The infant was a one year old healthy baby girl who was already walking and climbing. On 13-FEB-2013, she received vaccinations for MMR (manufacturer not specified), hepatitis A (manufacturer not specified), Hib (manufacturer not specified), PREVNAR, and varicella (manufacturer not specified).  That evening, the mother noticed the baby was irritable and feverish. After a call to the doctor, the mother was advised to give the baby TYLENOL and BENADRYL. The fever continued for several days and on the evening before the baby's scheduled pediatrician visit (exact date not specified but considered to be in 2013), the baby began having seizures. She was rushed to the Emergency Room (ER) where she went into cardiac and respiratory arrest and doctors placed her on a ventilator. The seizures and cardiac arrest left the baby with severe brain injury, encephalopathy, cortical vision impairment, truncal hypotonia, and kidney failure. After months of treatment at the hospital, she finally went home but her disabilities require specialized medical care and supervision around the clock for the rest of her life. The settlement would pay for the baby's constant high-level medical care for the rest of her life. The author of the article went on to say that the government and "Big Pharma" consistently tell the public that vaccines are safe and effective.  However, "the fact that vaccines kill and injure people, including young babies and infants, is not a fact that is in dispute". The outcome of cardiac and respiratory arrest was considered resolved. It was unknown whether the irritability, fevers, and seizures continued. The outcome of severe brain injury, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered not resolved as the patient required specialized medical care and supervision around the clock for the rest of her life. Causality assessment was considered related to MMR for all events. Causality assessment was not specifically stated for the other vaccines. Brain injury, seizures, cardiac arrest, respiratory arrest, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered disabling as the baby now required medical care around the clock for the rest of her life. Upon internal review, brain injury, cardiac arrest, respiratory arrest, seizures, encephalopathy, cortical vision impairment, and renal failure were considered to be medically significant. This is one of two reports from the same reporter (see case # 1509USA014655 discussing autism in boys in the same article). Additional information is not expected as there was no contact information.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Mechanical ventilation, Pyrexia, Renal failure, Respiratory arrest, Seizure
Clinical narrative: This initial spontaneous report was received via an online news article. The article described an infant who suffered a severe reaction to the MMR vaccine (manufacturer not specified). The infant was a one year old healthy baby girl who was already walking and climbing. On 13-FEB-2013, she received vaccinations for MMR (manufacturer not specified), hepatitis A (manufacturer not specified), Hib (manufacturer not specified), PREVNAR, and varicella (manufacturer not specified).  That evening, the mother noticed the baby was irritable and feverish. After a call to the doctor, the mother was advised to give the baby TYLENOL and BENADRYL. The fever continued for several days and on the evening before the baby's scheduled pediatrician visit (exact date not specified but considered to be in 2013), the baby began having seizures. She was rushed to the Emergency Room (ER) where she went into cardiac and respiratory arrest and doctors placed her on a ventilator. The seizures and cardiac arrest left the baby with severe brain injury, encephalopathy, cortical vision impairment, truncal hypotonia, and kidney failure. After months of treatment at the hospital, she finally went home but her disabilities require specialized medical care and supervision around the clock for the rest of her life. The settlement would pay for the baby's constant high-level medical care for the rest of her life. The author of the article went on to say that the government and "Big Pharma" consistently tell the public that vaccines are safe and effective.  However, "the fact that vaccines kill and injure people, including young babies and infants, is not a fact that is in dispute". The outcome of cardiac and respiratory arrest was considered resolved. It was unknown whether the irritability, fevers, and seizures continued. The outcome of severe brain injury, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered not resolved as the patient required specialized medical care and supervision around the clock for the rest of her life. Causality assessment was considered related to MMR for all events. Causality assessment was not specifically stated for the other vaccines. Brain injury, seizures, cardiac arrest, respiratory arrest, encephalopathy, cortical vision impairment, hypotonia, and kidney failure were considered disabling as the baby now required medical care around the clock for the rest of her life. Upon internal review, brain injury, cardiac arrest, respiratory arrest, seizures, encephalopathy, cortical vision impairment, and renal failure were considered to be medically significant. This is one of two reports from the same reporter (see case # 1509USA014655 discussing autism in boys in the same article). Additional information is not expected as there was no contact information.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Electromyogram abnormal, Herpes zoster, Hypoaesthesia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 30-MAR-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at his primary care physician's office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately April 2016 [reported as "shortly after" receiving the ZOSTAVAX], the patient began to experience tingling and numbness, accompanied by burning, originating in his hands and radiating outward thereafter. Shortly thereafter, the patient developed a painful rash and blisters on his upper back and shoulders. On or about 13-APR-2016, the patient presented to his primary care physician, and was diagnosed as suffering from shingles. It was planned that the patient would follow-up with a neurologist. The patient presented to a neurologist (exact date not provided), who performed an electromyogram/nerve conduction study (EMG/NCS) which indicated nerve damage. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Nerve conduction studies abnormal, Nerve injury, Paraesthesia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 30-MAR-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at his primary care physician's office for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately April 2016 [reported as "shortly after" receiving the ZOSTAVAX], the patient began to experience tingling and numbness, accompanied by burning, originating in his hands and radiating outward thereafter. Shortly thereafter, the patient developed a painful rash and blisters on his upper back and shoulders. On or about 13-APR-2016, the patient presented to his primary care physician, and was diagnosed as suffering from shingles. It was planned that the patient would follow-up with a neurologist. The patient presented to a neurologist (exact date not provided), who performed an electromyogram/nerve conduction study (EMG/NCS) which indicated nerve damage. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: Information has been received from a company employee, referring to her friend's 1 year old daughter. Information of current condition, concomitant therapy and historical condition was unknown. On an unknown date in 2018, the patient vaccinated with M-M-R II (lot number, expiration date, dose, frequency and route unknown) for prophylaxis (reported as received "series of shots recently"). On an unspecified date in 2018, the patient was admitted to an unspecified hospital, and was diagnosed with idiopathic thrombocytopenia (ITP). Unspecified treatment was given for the event. The outcome of the event was not provided. The causality assessment was not provided by the reporter. Upon internal review, idiopathic thrombocytopenia was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 14-AUG-2018, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (lot # N022583, expiry date: 20-JUN-2020) (dose, frequency and route were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported. No product quality complaint was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a currently 29-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (exact dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced allergic reaction to VARIVAX. The outcome of the event was unknown. The reporter considered the event to be related to VARIVAX. This is one of several reports regarding the same patient. Sender's Comments: US-009507513-1808USA002124.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Syncope
Clinical narrative: My 11 year old daughter received the HPV vaccine yesterday. She almost fainted after the shot and has had dizzy spells since the shot. I know that fainting and dizziness are common side effects, I just wanted to let you know for your data.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Joint stiffness, Joint swelling
Clinical narrative: During my annual physical exam (age 65) I received a PREVNAR 13 vaccine. On the following day and until now I have bad joint pain, stiffness and mild swelling of the joints which I never had prior to the injection. The worst symptoms are in my finger joints but also generalized. I also had a painful injection site which lasted only a few days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pruritus generalised
Clinical narrative: Pain, redness and hardness at injection site for 3 plus days, itching all over the body for 3 plus days. Patient treating itching with BENADRYL.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Patient reported that later in the evening she had difficulty breathing and ended up going to the emergency room. When being asked about medical history, she indicated she received a shingles vaccination that morning. The patient did not elaborate much more other than the ER indicated that that may be a side effect from the shot. Patient would not elaborate on the reaction much more than this.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Influenza like illness, Injection site pain, Pain
Clinical narrative: Severe pain on injection site, body ache, loss of appetite, low-grade flu-like symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: I received a shingles shot SHINGRIX on 8-6-2018. I was in immediate pain and redness at the injection site. I became chilled, extreme body aches, flu like symptoms. The next day my ear felt like ice picks were being stabbed in them. This pain also was on both sides of my jaw. I had to leave work. I have headaches, fever, upset stomach, tiredness, breathing problems of a weight being on my chest and shortness of breath. I am dizzy, have nausea, and can eat very little. My arms and legs feel very heavy. It is 8-15-2018 I am still have headaches, shivering, nausea, breathing problems of weight being on my chest and shortness of breath, dizzy and arms and legs feeling heavy. I still have a red spot at the injection site. When are these side effects going to go away?
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Electrocardiogram, Fatigue, Headache, Hypophagia
Clinical narrative: I received a shingles shot SHINGRIX on 8-6-2018. I was in immediate pain and redness at the injection site. I became chilled, extreme body aches, flu like symptoms. The next day my ear felt like ice picks were being stabbed in them. This pain also was on both sides of my jaw. I had to leave work. I have headaches, fever, upset stomach, tiredness, breathing problems of a weight being on my chest and shortness of breath. I am dizzy, have nausea, and can eat very little. My arms and legs feel very heavy. It is 8-15-2018 I am still have headaches, shivering, nausea, breathing problems of weight being on my chest and shortness of breath, dizzy and arms and legs feeling heavy. I still have a red spot at the injection site. When are these side effects going to go away?
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Limb discomfort, Nausea
Clinical narrative: I received a shingles shot SHINGRIX on 8-6-2018. I was in immediate pain and redness at the injection site. I became chilled, extreme body aches, flu like symptoms. The next day my ear felt like ice picks were being stabbed in them. This pain also was on both sides of my jaw. I had to leave work. I have headaches, fever, upset stomach, tiredness, breathing problems of a weight being on my chest and shortness of breath. I am dizzy, have nausea, and can eat very little. My arms and legs feel very heavy. It is 8-15-2018 I am still have headaches, shivering, nausea, breathing problems of weight being on my chest and shortness of breath, dizzy and arms and legs feeling heavy. I still have a red spot at the injection site. When are these side effects going to go away?
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw, Pyrexia
Clinical narrative: I received a shingles shot SHINGRIX on 8-6-2018. I was in immediate pain and redness at the injection site. I became chilled, extreme body aches, flu like symptoms. The next day my ear felt like ice picks were being stabbed in them. This pain also was on both sides of my jaw. I had to leave work. I have headaches, fever, upset stomach, tiredness, breathing problems of a weight being on my chest and shortness of breath. I am dizzy, have nausea, and can eat very little. My arms and legs feel very heavy. It is 8-15-2018 I am still have headaches, shivering, nausea, breathing problems of weight being on my chest and shortness of breath, dizzy and arms and legs feeling heavy. I still have a red spot at the injection site. When are these side effects going to go away?
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Insomnia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: SHINGRIX 1st shot. Terrible arm pain, the worst I've ever had with a shot. I also had achy back pain from that shoulder to the base of my neck. Had to put arm in and out of sling, aspirins, and iced it for two days. The pain in the arm started about 4 hrs after shot and continued to get worse through the day. I don't believe I slept that night due to the slightest movement cause the arm to hurt so much. It took about days to really feel better. Certainly not wanting to go through this again.
Age: 70.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site vesicles, Peripheral swelling, Pruritus, Rash
Clinical narrative: 3 days after he received PNEUMOVAX 23 and AFLURIA QUAD arm became red, swollen, itch, bumpy and the Band-Aid has left a blistering mark. Pt was admitted to urgent care and was prescribed KEFLEX 500g TID x 7D and hydrocortisone 0.5% cream BID x 7D.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: 18 hrs following SHINGRIX injection patient developed Bell's Palsy.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Rash, Vaccination site mass
Clinical narrative: Parent noted a lump and redness at vaccine site left thigh. No fever. Has rash over chest, abdomen and neck. Cool compress to area. TYLENOL for discomfort. F/U if symptoms worsen.
Age: 12.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Chills, Headache, Influenza virus test negative, Injection site swelling, Nausea
Clinical narrative: Patient had chills, nauseated, headache, and swelling at the injection site. Patient went to an Express Care and was examine by a Doctor. Patient was sent home.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Influenza like illness, Nausea
Clinical narrative: I received the second singles immunization at a local pharmacy on August 8th. No reaction that evening. But by the next morning I had flu-like symptoms. These included nausea, headache, and intense joint pain. for most of that day. Also had a 3 - 3 1/2 inch red spot just beneath the injection site. Symptom lasted through the day, were lessened the next day and gone my the third day.
Age: 33.0
Sex: M
Vaccine: MMR, MNQ, TYP, YF
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Peripheral coldness
Clinical narrative: 4 hours following the yellow fever shot and 3 other shots, I felt dizzy, nauseous, hands and feet cold to the touch, pain in the calves and thighs, and a severe headache. I went to my clinic and they referred me to the Emergency Room. They checked my vitals and stated that they look fine. I was given TYLENOL and Ibuprofen and was discharged. The medicine helped thay night, but the very next day all the symptoms returned.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Client passed out in the elevator, on her way out. Pallor noted. Mother stated she "blacked out" but denied hitting her head on the wall as she was holding her daughter's arm. Placed client flat on her back with legs elevated by a foam wedge. She recovered completely and answered questions coherently. Pulse rate was regular and strong. A pouch of juice was given. Assisted by the RN supervisor to stand up and walk to the wheelchair to transport her to her vehicle. Steady gait noted. Sent home in stable condition, accompanied by her mother.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Pain, soreness, fatigue.
Age: 41.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site pain, Mobility decreased, Nausea, Neck pain
Clinical narrative: REPORTED NAUSEA, VOMITING, HEADACHE AND PAIN IN THE LEFT ARM RADIATING TO THE SHOULDER AND NECK. REPORTED TROUBLE MOVING HER ARM. REFERRED TO OCCUPATIONAL HEALTH FOR EVALUATION/FOLLOW UP.
Age: 41.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain, Vomiting
Clinical narrative: REPORTED NAUSEA, VOMITING, HEADACHE AND PAIN IN THE LEFT ARM RADIATING TO THE SHOULDER AND NECK. REPORTED TROUBLE MOVING HER ARM. REFERRED TO OCCUPATIONAL HEALTH FOR EVALUATION/FOLLOW UP.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: Dyspnoea, Erythema, Eye swelling, Feeling hot, Injection site erythema
Clinical narrative: Patient noticed & experienced symptoms that started approximately 6 hrs after vaccine administration. She broke out in a rash, felt"hot" and "jumpy". She has no SOB, dyspnea, swelling of lips or respiratory distress. Local diffuse redness noted at injection site, redness radiates to left scapula and clavicle. Very warm to touch.Red rash on trunk, arms,face & abdomen that continued and worsened throughout the day of vaccination and the following day. Patient presented to clinic this morning with additional C/O of "throat feeling tight", lips & eyes swelling. She has been taking all medications as prescribed.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: Lip swelling, Nervousness, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient noticed & experienced symptoms that started approximately 6 hrs after vaccine administration. She broke out in a rash, felt"hot" and "jumpy". She has no SOB, dyspnea, swelling of lips or respiratory distress. Local diffuse redness noted at injection site, redness radiates to left scapula and clavicle. Very warm to touch.Red rash on trunk, arms,face & abdomen that continued and worsened throughout the day of vaccination and the following day. Patient presented to clinic this morning with additional C/O of "throat feeling tight", lips & eyes swelling. She has been taking all medications as prescribed.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: Throat tightness
Clinical narrative: Patient noticed & experienced symptoms that started approximately 6 hrs after vaccine administration. She broke out in a rash, felt"hot" and "jumpy". She has no SOB, dyspnea, swelling of lips or respiratory distress. Local diffuse redness noted at injection site, redness radiates to left scapula and clavicle. Very warm to touch.Red rash on trunk, arms,face & abdomen that continued and worsened throughout the day of vaccination and the following day. Patient presented to clinic this morning with additional C/O of "throat feeling tight", lips & eyes swelling. She has been taking all medications as prescribed.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: NO ADVERSE EVENT, DR AWARE. GIVEN TO WRONG PATIENT.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Hyperhidrosis
Clinical narrative: About 14 hours after dose was given, patient experiences labored breathing and sweating for four hours.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blindness, Ear discomfort, Feeling abnormal, Mydriasis, Ocular hyperaemia
Clinical narrative: 5 Minutes after injections pt states he didn't feel right, cannot see anything, black. Checked pupils and dilated 5-6 mm and no reaction to light. Stated stomach did not feel good and funny feeling in ears. Felt like he was going to have headache. Client was pale, BP 98/56 HR 84 Resp 20. Pt sat in chair for 10 minutes and stated he could see again. Checked pupils again 2 mm and reacted to light, whites of eyes were a little blood shot. Monitored pt. for 20 minutes and no problems. Asked mother if she wanted me to contact his PCP for eval she declined. Recommended to watch pt. have him lie down for a while give ibuprofen. If problems occur call EMS or PCP.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pallor
Clinical narrative: 5 Minutes after injections pt states he didn't feel right, cannot see anything, black. Checked pupils and dilated 5-6 mm and no reaction to light. Stated stomach did not feel good and funny feeling in ears. Felt like he was going to have headache. Client was pale, BP 98/56 HR 84 Resp 20. Pt sat in chair for 10 minutes and stated he could see again. Checked pupils again 2 mm and reacted to light, whites of eyes were a little blood shot. Monitored pt. for 20 minutes and no problems. Asked mother if she wanted me to contact his PCP for eval she declined. Recommended to watch pt. have him lie down for a while give ibuprofen. If problems occur call EMS or PCP.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Rash erythematous
Clinical narrative: Patient was given the SHINGRIX vaccine subsutaneously and not IM. She suffered a red rash and some fluid build up which resolved in a couple days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: LOCAL REACTION - HOT RED BRUISED AROUND AREA OF INJECTION. FLU LIKE SYMPTOMS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, pain at the site of vaccine within a few hours of the shot. Advised for TYLENOL/ibuprofen, icing.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Injection site pruritus
Clinical narrative: Extreme flu-like symptoms of joints and full-body aching, light headache and fever. Sore arm area of shot and swelling, lasting two days, then intense itching in 3" x 3" area of shot, lessening in 5 days and gone in 1 1/2 weeks. I saw the pharmacist.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain, Pyrexia
Clinical narrative: Extreme flu-like symptoms of joints and full-body aching, light headache and fever. Sore arm area of shot and swelling, lasting two days, then intense itching in 3" x 3" area of shot, lessening in 5 days and gone in 1 1/2 weeks. I saw the pharmacist.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Discomfort, Infection, Limb discomfort
Clinical narrative: My right side felt heavy all time. It felt as if it going come again arm burn and heavy when infection come.
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA223710, 2018SA223733, 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves 5 year old (5 year 8 months) patient of an unknown demographics who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received Tdap on 8-16-2018 MCIR records when combined showed Tdap given at PCP on7/8/2015 and was UTD - did not need dose received in LHD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Patient developed a full body rash on 8/16/18.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Asthenia, Crying, Diarrhoea, Diet refusal, Injection site erythema
Clinical narrative: LPN 8/14/2018 11:49:11 AM greater temp of 101.2 (rectal); resolved to 99.6 (rectal) after TYLENOL given. Having explosive diarrhea - has gone through 3 outfits all ready today. Extremely lethargic (has no energy; just laying on mom instead of playing with her toys); very restless; was up every 45 minutes fussing and crying. Not interested in nursing -- only taking 2 oz q 4 hours; mom is offering 2 mL TYLENOL. Injection sites are a little swollen (similar to previous injections) LPN 8/15/2018 11:10:28 AM > mom states that she is doing much better: mom states that child's fever broke at 0300; finally slept from 0330-0830. States that she finally took 3 oz bottle this AM; mom is still offering 2 oz PEDIALYTE every couple hours; child has voided x 1 so far today and has not had any dirty diapers yet today (stooled x5 yesterday). LPN 8/15/2018 12:21:38 PM > mom states that child was noted to have redness around the injection site at 2200 and was noted to have a golf ball sized raised spot on right leg. Mom states that swelling resolves when TYLENOL is given and applies ice. States that swelling returns but no longer red -- appt scheduled for 1000 on 8/16, LPN 8/16/2018 10:26:43 AM > message left at 1343 on 8/15 retrieved from voicemail at his time: mom just noticed what looks like a mosquito bite right on inside of thigh (mom is allergic to mosquito bites so thinks this is child's issue too); applied HCC and looks drastically better so doesn't think that needs to be seen. Still having a little diarrhea but more solid than before.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling, Irritability, Lethargy, Restlessness
Clinical narrative: LPN 8/14/2018 11:49:11 AM greater temp of 101.2 (rectal); resolved to 99.6 (rectal) after TYLENOL given. Having explosive diarrhea - has gone through 3 outfits all ready today. Extremely lethargic (has no energy; just laying on mom instead of playing with her toys); very restless; was up every 45 minutes fussing and crying. Not interested in nursing -- only taking 2 oz q 4 hours; mom is offering 2 mL TYLENOL. Injection sites are a little swollen (similar to previous injections) LPN 8/15/2018 11:10:28 AM > mom states that she is doing much better: mom states that child's fever broke at 0300; finally slept from 0330-0830. States that she finally took 3 oz bottle this AM; mom is still offering 2 oz PEDIALYTE every couple hours; child has voided x 1 so far today and has not had any dirty diapers yet today (stooled x5 yesterday). LPN 8/15/2018 12:21:38 PM > mom states that child was noted to have redness around the injection site at 2200 and was noted to have a golf ball sized raised spot on right leg. Mom states that swelling resolves when TYLENOL is given and applies ice. States that swelling returns but no longer red -- appt scheduled for 1000 on 8/16, LPN 8/16/2018 10:26:43 AM > message left at 1343 on 8/15 retrieved from voicemail at his time: mom just noticed what looks like a mosquito bite right on inside of thigh (mom is allergic to mosquito bites so thinks this is child's issue too); applied HCC and looks drastically better so doesn't think that needs to be seen. Still having a little diarrhea but more solid than before.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe headache which was not helped by TYLENOL. Ice pack gave some relieve. Continued until about 6 am Wednesday, Aug 15.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient says she always passes out when getting an injection. I laid her down on the exam table and gave her the injection and she was fine for about 30 seconds and then passed out and appeared to have a vasovagal episode. It lasted about 30-45 seconds and then she was aware of her surroundings. I made her continue to lay down for 5 minutes and slowly let her sit up and then dangle her legs. She then moved to a chair and she sat there another 10 minutes with her mother before her mother took her home.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pallor, Tremor, Visual impairment, Vomiting
Clinical narrative: Vaccines were administered, patient became shaky, pale, sick to his stomach and was seeing colors upon standing. Patient threw up 4 times.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: Patient reports that she was very sore, noted fever, chills, upset stomach and headache after receiving her second SHINGRIX vaccine. She ended up staying home from work and laid in bed all day. She notes that she feels much better today, 08/16/2018.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Back pain, Facial asymmetry, Headache, Laboratory test normal
Clinical narrative: That night I got a red rash on the back of my neck and a headache. The next morning my husband found me with my face all contorted and not able to speak real words, only gibberish. My back had a terrible pain all through it. He called 911 and they took me to the hospital where I still was not speaking words but I thought I was. I could hear myself saying actual words but everyone around me said I was not. I was in the hospital for 5 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle contractions involuntary, Rash, Rash erythematous, Thoracic vertebral fracture
Clinical narrative: That night I got a red rash on the back of my neck and a headache. The next morning my husband found me with my face all contorted and not able to speak real words, only gibberish. My back had a terrible pain all through it. He called 911 and they took me to the hospital where I still was not speaking words but I thought I was. I could hear myself saying actual words but everyone around me said I was not. I was in the hospital for 5 days.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N020010 and expiration date of 13-JAN-2019, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -14 Celsius degrees to -10 Celsius degrees for 30 minutes. Previous temperature excursion was reported as -14 Celsius degrees to -10 Celsius degrees for 12 hours and 30 minutes. The vaccine was reconstituted with properly stored DILUENT MRK. No adverse effects were reported. No digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA003654: US-009507513-1808USA003614.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pruritus and erythema urticarial. On an unknown date, the outcome of the pruritus was unknown and the outcome of the erythema urticarial was recovered/resolved. It was unknown if the reporter considered the pruritus and erythema urticarial to be related to SHINGRIX. Additional details reported as follows: This case was reported by the medical assistant (MA). The age at vaccination was not reported. Within 24 hours after vaccination the patient experienced itching and red welts across her abdomen. The red welts lasted for about 90 minutes and completely went away after. The batch number of SHINGRIX was unknown. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (about 10 years before the date of reporting). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever, chills and fatigue. On an unknown date, the outcome of the fever, chills and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, chills and fatigue to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to the physician. The age at vaccination was not reported. The reporter reported that, about 2 and a half months before the date of reporting she received a dose of SHINGRIX (at 10 o clock) in right arm. The reporter stated that, later the evening of her shot, she experienced fever, chills and shivering. She also went to bed because she was so tired. The reporter noted extreme fatigue for 36 hours. The patient also noted fever which recorded as 102 Degree F. The pharmacy where they received the vaccine was onsite at the physician office. This case was linked to case US2018141995, reported by the same reporter.