chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Patient described feeling like something was "off " as soon as needle punctured her arm. She had a red, raised local reaction at the injection site, and developed a rash that spread all the way to her elbow. This resolved within a week of injection. She also described feeling like she was coming down with something, a general sickness feeling that kept her in bed. Approximately 11 days after injection she experienced a breakout of hives across her chest and forearm that she is still experiencing at 13 days post vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Patient described feeling like something was "off " as soon as needle punctured her arm. She had a red, raised local reaction at the injection site, and developed a rash that spread all the way to her elbow. This resolved within a week of injection. She also described feeling like she was coming down with something, a general sickness feeling that kept her in bed. Approximately 11 days after injection she experienced a breakout of hives across her chest and forearm that she is still experiencing at 13 days post vaccine.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: C/O extreme chills and body aches that kept her in bed for 26 hours following mandatory flu vaccine. Denies respiratory problems, no swelling of lips or throat, fever, or pain at injection site.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Abscess drainage, Endodontic procedure, Hypersensitivity, Noninfective sialoadenitis, Pain
Clinical narrative: Swelling of glands and under tongue after an hour. Progressively more swollen until ER visit 9/25 at 3 AM. Given prednisone and BENADRYL for suspected allergic reaction. Dentist apt at 11:00 9/25 determined infection under bottom front teeth and referral to endodontist. Start amoxicillin. 9/26 emergency root canal by Dr. for immense swelling and pain, unable to set apt with endo quick enough to wait. 9/28 emergency root canal number two along with draining of infected tissue under tongue. Prescription changed to AUGMENTIN and methylprednisolone pack. 10/2 return trip to dentist with continued tissue inflammation under tongue and left side glands. Possible third root canal.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Salivary gland enlargement, Soft tissue inflammation
Clinical narrative: Swelling of glands and under tongue after an hour. Progressively more swollen until ER visit 9/25 at 3 AM. Given prednisone and BENADRYL for suspected allergic reaction. Dentist apt at 11:00 9/25 determined infection under bottom front teeth and referral to endodontist. Start amoxicillin. 9/26 emergency root canal by Dr. for immense swelling and pain, unable to set apt with endo quick enough to wait. 9/28 emergency root canal number two along with draining of infected tissue under tongue. Prescription changed to AUGMENTIN and methylprednisolone pack. 10/2 return trip to dentist with continued tissue inflammation under tongue and left side glands. Possible third root canal.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Pain
Clinical narrative: On 1 Jun 2018, patient experienced left shoulder pain limiting range-of-motion x 7 days s/p Anthrax inoculation left arm. On-set of symptoms of pain and limitation of motion within 24 hours of receiving injection but did not present to clinic until today as he expected symptoms to resolve. Physical Exam: Musculoskeletal: Left shoulder skin intact without erythema, edema or ecchymosis, small palpable nodule on lateral deltoid, ROM in abduction/external rotation and adduction/internal rotation limited by pain. Patient was instructed on home exercises including stretching and light weights (2 pounds). Stretches included cross body arm pull, overhead arm pull, cross back arm pull, neck stretches, starting with 2 sets of 10 reps and increasing to 3 sets of 10 reps. Shoulder pain completely resolved by 5 Jul 2018.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Initially, pain at injection site (which is still present but mildly improved). Then, muscle cramps/pain of legs > hands as well as tingling of feet and legs that began around midnight/12 am, 10/02/2018, about 5 hours after the vaccine.....did not attribute it to the vaccine initially? thought it was my imagination but it continued and hindered my sleep throughout the night and this AM it persists and then I thought about the fact that I did have the flu vaccine and began researching side effects (never had these symptoms with prior flu vaccines).
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from an nurse practitioner and refers to a 69 year old female patient. There was no information regarding the patient's medical history, concomitant medication, drug reactions and allergies provided. On 28-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, first dose for prophylaxis (lot# M037533, expiration date 17-MAY-2018). On 23-SEP-2018, the patient received second dose of PNEUMOVAX 23 (lot# N014946, expiration date: 01-FEB-2019). Both vaccines were properly stored prior to administration. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dysphonia, Loss of personal independence in daily activities, Migraine, Nausea
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date, site and route of administration were not reported) for prophylaxis. On the same date, the patient was vaccinated concomitantly with MENACTRA. On an unknown date, the patient might had been experienced migraines, nausea, hoarseness and trouble running in Gym class before and after vaccination. It was also reported as ''the nurse believed the patient had these symptoms before the GARDASIL 9, however the patient's parents believed the symptoms started after the vaccine''. The outcome of the events was unknown. The causality assessments were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Nervous system disorder, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-MAY-2013, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 21-FEB-2017. As a direct result of the ZOSTAVAX, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and seriousness of her neurologic condition resulting from the ZOSTAVAX vaccine. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of her use of ZOSTAVAX. The outcome of the events was unknown. Causality assessment was related. Shingles outbreak and neurologic condition were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-MAY-2013, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 21-FEB-2017. As a direct result of the ZOSTAVAX, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and seriousness of her neurologic condition resulting from the ZOSTAVAX vaccine. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of her use of ZOSTAVAX. The outcome of the events was unknown. Causality assessment was related. Shingles outbreak and neurologic condition were considered to be disabling. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a patient's daughter and refers to a 66 year old female patient. The patient's concurrent conditions included diabetes, depression, high blood pressure, anemia, high cholesterol. The patient's medical history was not provided. Her concomitant medications included quite a few diabetes medications, depression medications, high blood pressure medications and anemia medications. The patient had no drug reactions or allergies. On 26-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 subcutaneously or intramuscularly, lot # R012497, expiration date 08-JAN-2020. On 27-SEP-2018, the patient experienced injection site swelling, redness and pain. The patient put ice on injection site and took TYLENOL for the pain. The patient did not seek any medical attention. No diagnostic studies were performed. The patient did not recover from the events at the time of reporting. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Culture throat negative, Erythema, Rash, Rash generalised, Streptococcus test negative
Clinical narrative: Rash - began on neck and cheeks less than 24 hours after vaccination and spread over entire body within 36 hours. Also had redness and puffiness around the eyes by 48 hours. He was seen by his Pediatrician 2 days post-vaccination. Tested for strep due to rash appearance. Prescribed ZYRTEC - 2.5ml by mouth daily x 7-10 days. Rash resolved by 30 September, but as of 08:30am on 2 October, puffiness around eyes still remains.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: Rash - began on neck and cheeks less than 24 hours after vaccination and spread over entire body within 36 hours. Also had redness and puffiness around the eyes by 48 hours. He was seen by his Pediatrician 2 days post-vaccination. Tested for strep due to rash appearance. Prescribed ZYRTEC - 2.5ml by mouth daily x 7-10 days. Rash resolved by 30 September, but as of 08:30am on 2 October, puffiness around eyes still remains.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Severe allergic reaction within 3 hours of vaccine, arm swollen and red, went to ER and was given MEDROL dose pack and told to buy BENADRYL.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: I was 35 weeks pregnant at the time I received the vaccine. Estimated due date is 10/12/18. Estimated birth weight is >10 pounds if delivered at 40 weeks. Two days after receiving the vaccine, I developed a red, bumpy, itchy rash that went down the sides of my back. The rash was symmetrical. It was also on my upper arms. The following day, it was also on my lower arms and lower back and was no longer symmetrical. There were also a few bumps on my abdomen and legs. The bumps resemble insect bites. They go away after a few days and leave marks on my body, and new ones replace them. It's now a month later and new bumps are still appearing. The long term outcome is unknown since the bumps are still appearing.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: I was 35 weeks pregnant at the time I received the vaccine. Estimated due date is 10/12/18. Estimated birth weight is >10 pounds if delivered at 40 weeks. Two days after receiving the vaccine, I developed a red, bumpy, itchy rash that went down the sides of my back. The rash was symmetrical. It was also on my upper arms. The following day, it was also on my lower arms and lower back and was no longer symmetrical. There were also a few bumps on my abdomen and legs. The bumps resemble insect bites. They go away after a few days and leave marks on my body, and new ones replace them. It's now a month later and new bumps are still appearing. The long term outcome is unknown since the bumps are still appearing.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient states 1 day after receiving vaccination her arm was red, hard, swollen. She noted the reaction was a few inches below the actual injection site. After a few more days she presented with red itchy areas on both arms and chest area mainly, however there were also a few spots on her legs.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pain
Clinical narrative: Patient experienced muscle aches, soreness, lethargy the next couple of days.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Injection site erythema, Rash
Clinical narrative: Patient reports a couple days after recieving vaccine, having LBP that went to his left side of his stomach, knee pain, rash on left leg, and 4inches of redness at injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reported her arm was red the size of a softball, she reported it was warm to the touch, swollen and painful It was 4.5 days before it went away.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pt complaining of shoulder pain and decrease range of motion starting one day after vaccination and continuing over next week. Pain and range of motion has improved since then but pt continues to complain of soreness.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Paraesthesia, Rash, Skin warm
Clinical narrative: 9-29-18 rash on lower legs below knee leg warm to touch, burning and tingle. 10-1-18, ER visit - received antibiotics and prescription antibiotic (doxycycline) 100 mg BID x 10 days. Patient states similar symptoms last year.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: Patient complained of a rheumatoid arthritis flare up the day after receiving her high-dose flu shot.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Paraesthesia, Throat tightness
Clinical narrative: Tightness in throat, numbness in tongue and tingling in R hand. She went to the ER at 15:30 to get checked out. She reported that they gave her IM BENADRYL. She stated that her symptoms resolved in the next hour after that.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Patient reports swollen injection site, reddish in color, then whelps all around at back of neck, arms and chest since yesterday but seems to be diminishing today.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dysstasia, Flushing, Hypoaesthesia, Pruritus generalised
Clinical narrative: Ambulated to Employee health c/o itching all over her skin, felt like she couldn't stand, hands and legs were numb. Flush face. Transported to the ER.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Blood test, Cough, Crying, Fatigue
Clinical narrative: 9/14/18- day of vaccinations, one shot bled a lot. Symptoms: hot, sweaty in the evening, fussy; 9/15/18- large size of half dollar, possibly bigger, hot, swelling and lump under skin on left leg where shot was on upper thigh, fever of 100.6; called nurse line at clinic about lump, they stated it was normal, apply ice pack and give TYLENOL. I did not give TYLENOL. 9/16/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/17/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/18/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, runny nose and wet cough starts; 9/19/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, slight runny nose still; 9/20/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/21/18- the day his demeanor changes, large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8- very tired and fussy, cries every time I move him, nurses from 7p-11p- does not want to come off, cries when not nursing, doesn't smile today; 9/22/18- wakes at 2am or 3am crying in sleep, just keeps crying cannot get to nurse, finally able to get him to nurse by 8am/9am, falls back asleep, will only sleep on me, cries if I move him. Call nurse line at clinic, she recommends we go to the ER based on his symptoms and age, fever of 101 at ER, TYLENOL given, lump still present under skin on left leg, looks more like a large bruise now, still size of half dollar.- We spend 6 hours in the ER, they run blood at urine. No UTI, No bacteria in blood but did not get all results prior to being discharged. They recommended TYLENOL and diagnosed as a virus. No smile today. If he wasn't sleeping, he was awake and crying or staring lethargically; 9/23/18- lump still present under skin on left leg, looks more like a bruise now, still size of half dollar, fever 100.5, still no smiles today, give TYLENOL dose at 7:30pm, got slight smile with bath time; 9/24/18- lump still present under skin on left leg, looks more like a bruise now, still size between half dollar and quarter, no fever today, wakes up with red rash all over body, we go to his primary care physician, rash- diagnosed as viral rash, given antibiotic for possible infection from shot- DID NOT GIVE antibiotic. Smiles today, slight wet cough present, diagnosed with virus. 9/29/18- bruise and lump still present quarter size on left thigh. Has been back to normal self since 9/25/18. 10/2/18- bruise and lump still present- quarter size.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeling hot, Hyperhidrosis, Injection site bruising, Injection site haemorrhage, Injection site mass
Clinical narrative: 9/14/18- day of vaccinations, one shot bled a lot. Symptoms: hot, sweaty in the evening, fussy; 9/15/18- large size of half dollar, possibly bigger, hot, swelling and lump under skin on left leg where shot was on upper thigh, fever of 100.6; called nurse line at clinic about lump, they stated it was normal, apply ice pack and give TYLENOL. I did not give TYLENOL. 9/16/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/17/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/18/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, runny nose and wet cough starts; 9/19/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, slight runny nose still; 9/20/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/21/18- the day his demeanor changes, large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8- very tired and fussy, cries every time I move him, nurses from 7p-11p- does not want to come off, cries when not nursing, doesn't smile today; 9/22/18- wakes at 2am or 3am crying in sleep, just keeps crying cannot get to nurse, finally able to get him to nurse by 8am/9am, falls back asleep, will only sleep on me, cries if I move him. Call nurse line at clinic, she recommends we go to the ER based on his symptoms and age, fever of 101 at ER, TYLENOL given, lump still present under skin on left leg, looks more like a large bruise now, still size of half dollar.- We spend 6 hours in the ER, they run blood at urine. No UTI, No bacteria in blood but did not get all results prior to being discharged. They recommended TYLENOL and diagnosed as a virus. No smile today. If he wasn't sleeping, he was awake and crying or staring lethargically; 9/23/18- lump still present under skin on left leg, looks more like a bruise now, still size of half dollar, fever 100.5, still no smiles today, give TYLENOL dose at 7:30pm, got slight smile with bath time; 9/24/18- lump still present under skin on left leg, looks more like a bruise now, still size between half dollar and quarter, no fever today, wakes up with red rash all over body, we go to his primary care physician, rash- diagnosed as viral rash, given antibiotic for possible infection from shot- DID NOT GIVE antibiotic. Smiles today, slight wet cough present, diagnosed with virus. 9/29/18- bruise and lump still present quarter size on left thigh. Has been back to normal self since 9/25/18. 10/2/18- bruise and lump still present- quarter size.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Irritability, Lethargy
Clinical narrative: 9/14/18- day of vaccinations, one shot bled a lot. Symptoms: hot, sweaty in the evening, fussy; 9/15/18- large size of half dollar, possibly bigger, hot, swelling and lump under skin on left leg where shot was on upper thigh, fever of 100.6; called nurse line at clinic about lump, they stated it was normal, apply ice pack and give TYLENOL. I did not give TYLENOL. 9/16/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/17/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/18/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, runny nose and wet cough starts; 9/19/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, slight runny nose still; 9/20/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/21/18- the day his demeanor changes, large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8- very tired and fussy, cries every time I move him, nurses from 7p-11p- does not want to come off, cries when not nursing, doesn't smile today; 9/22/18- wakes at 2am or 3am crying in sleep, just keeps crying cannot get to nurse, finally able to get him to nurse by 8am/9am, falls back asleep, will only sleep on me, cries if I move him. Call nurse line at clinic, she recommends we go to the ER based on his symptoms and age, fever of 101 at ER, TYLENOL given, lump still present under skin on left leg, looks more like a large bruise now, still size of half dollar.- We spend 6 hours in the ER, they run blood at urine. No UTI, No bacteria in blood but did not get all results prior to being discharged. They recommended TYLENOL and diagnosed as a virus. No smile today. If he wasn't sleeping, he was awake and crying or staring lethargically; 9/23/18- lump still present under skin on left leg, looks more like a bruise now, still size of half dollar, fever 100.5, still no smiles today, give TYLENOL dose at 7:30pm, got slight smile with bath time; 9/24/18- lump still present under skin on left leg, looks more like a bruise now, still size between half dollar and quarter, no fever today, wakes up with red rash all over body, we go to his primary care physician, rash- diagnosed as viral rash, given antibiotic for possible infection from shot- DID NOT GIVE antibiotic. Smiles today, slight wet cough present, diagnosed with virus. 9/29/18- bruise and lump still present quarter size on left thigh. Has been back to normal self since 9/25/18. 10/2/18- bruise and lump still present- quarter size.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rhinorrhoea, Staring
Clinical narrative: 9/14/18- day of vaccinations, one shot bled a lot. Symptoms: hot, sweaty in the evening, fussy; 9/15/18- large size of half dollar, possibly bigger, hot, swelling and lump under skin on left leg where shot was on upper thigh, fever of 100.6; called nurse line at clinic about lump, they stated it was normal, apply ice pack and give TYLENOL. I did not give TYLENOL. 9/16/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/17/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/18/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, runny nose and wet cough starts; 9/19/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, slight runny nose still; 9/20/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/21/18- the day his demeanor changes, large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8- very tired and fussy, cries every time I move him, nurses from 7p-11p- does not want to come off, cries when not nursing, doesn't smile today; 9/22/18- wakes at 2am or 3am crying in sleep, just keeps crying cannot get to nurse, finally able to get him to nurse by 8am/9am, falls back asleep, will only sleep on me, cries if I move him. Call nurse line at clinic, she recommends we go to the ER based on his symptoms and age, fever of 101 at ER, TYLENOL given, lump still present under skin on left leg, looks more like a large bruise now, still size of half dollar.- We spend 6 hours in the ER, they run blood at urine. No UTI, No bacteria in blood but did not get all results prior to being discharged. They recommended TYLENOL and diagnosed as a virus. No smile today. If he wasn't sleeping, he was awake and crying or staring lethargically; 9/23/18- lump still present under skin on left leg, looks more like a bruise now, still size of half dollar, fever 100.5, still no smiles today, give TYLENOL dose at 7:30pm, got slight smile with bath time; 9/24/18- lump still present under skin on left leg, looks more like a bruise now, still size between half dollar and quarter, no fever today, wakes up with red rash all over body, we go to his primary care physician, rash- diagnosed as viral rash, given antibiotic for possible infection from shot- DID NOT GIVE antibiotic. Smiles today, slight wet cough present, diagnosed with virus. 9/29/18- bruise and lump still present quarter size on left thigh. Has been back to normal self since 9/25/18. 10/2/18- bruise and lump still present- quarter size.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis normal, Viral infection, Viral rash
Clinical narrative: 9/14/18- day of vaccinations, one shot bled a lot. Symptoms: hot, sweaty in the evening, fussy; 9/15/18- large size of half dollar, possibly bigger, hot, swelling and lump under skin on left leg where shot was on upper thigh, fever of 100.6; called nurse line at clinic about lump, they stated it was normal, apply ice pack and give TYLENOL. I did not give TYLENOL. 9/16/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/17/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/18/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, runny nose and wet cough starts; 9/19/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8, slight runny nose still; 9/20/18- large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8; 9/21/18- the day his demeanor changes, large size of half dollar, hot, swelling and lump under skin on left leg still present, mild fever ranging and fluctuating from 98 to 100.6/100.8- very tired and fussy, cries every time I move him, nurses from 7p-11p- does not want to come off, cries when not nursing, doesn't smile today; 9/22/18- wakes at 2am or 3am crying in sleep, just keeps crying cannot get to nurse, finally able to get him to nurse by 8am/9am, falls back asleep, will only sleep on me, cries if I move him. Call nurse line at clinic, she recommends we go to the ER based on his symptoms and age, fever of 101 at ER, TYLENOL given, lump still present under skin on left leg, looks more like a large bruise now, still size of half dollar.- We spend 6 hours in the ER, they run blood at urine. No UTI, No bacteria in blood but did not get all results prior to being discharged. They recommended TYLENOL and diagnosed as a virus. No smile today. If he wasn't sleeping, he was awake and crying or staring lethargically; 9/23/18- lump still present under skin on left leg, looks more like a bruise now, still size of half dollar, fever 100.5, still no smiles today, give TYLENOL dose at 7:30pm, got slight smile with bath time; 9/24/18- lump still present under skin on left leg, looks more like a bruise now, still size between half dollar and quarter, no fever today, wakes up with red rash all over body, we go to his primary care physician, rash- diagnosed as viral rash, given antibiotic for possible infection from shot- DID NOT GIVE antibiotic. Smiles today, slight wet cough present, diagnosed with virus. 9/29/18- bruise and lump still present quarter size on left thigh. Has been back to normal self since 9/25/18. 10/2/18- bruise and lump still present- quarter size.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Musculoskeletal stiffness, Paraesthesia, Peripheral swelling
Clinical narrative: Right arm with swelling, redness, warmth, tingling, stiffness x greater than 4 days. Pt. received PNEUMOVAX vaccine to left deltoid and influenza to right deltoid. Pt. used ice, stretching, and TYLENOL to site before contacting Physician.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient was brought in for possible reaction to tdap. It looked like a bug bite for weeks and today a round welt appeared but no longer present on right upper arm. She denies pain or itching. Denies SOB.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal distension
Clinical narrative: Patient claims her stomach is bloated due to the flu shot.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Paraesthesia
Clinical narrative: Client pulled back when needle was inserted stating that she had severe pain. Some vaccine dripped down clients arm. Complained of tingling of her hand. Check with client an hour later, still having the sensation. Normal movement. TC 10/2, improved slightly but still pronounced. Advised to contact her physician tomorrow if not completely resolved.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia, Tremor
Clinical narrative: Flu like symptoms - fever, shaking for about 8-hours.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-SEP-2018, the patient was inadvertently vaccinated with a dose of VAQTA, lot # N016805, intramuscular, which expired on 04-SEP-2018 (exact dose, frequency and site of administration were not reported). No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a 15-year-old female patient. The patient had no medical history, concurrent conditions, concomitant therapies, drugs reactions or allergies. On an unknown date (reported as a couple of months ago), the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date not provided) for prophylaxis. On an unknown date (reported 3 days later), the patient's mother called to report that the patient experienced rash at the injection site. There were no lab diagnostics performed. The patient sought medical attention and was advised to take oral BENADRYL (also reported as no treatment was given for the event). On an unknown date, the patient recovered. The relatedness between the GARDASIL 9 and injection site rash was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 25-SEP-2018, the patient was vaccinated with an expired dose of VAQTA, intramuscularly, lot # N019924, expiration date 02-SEP-2018 (exact dose and anatomical localization was not reported). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2018 (reported as "a few weeks ago"), the patient was vaccinated with GARDASIL 9 intramuscularly (dose, site of administration, lot # and expiration date were not reported) for prophylaxis. A few minutes after the vaccination the patient experienced syncope. She experienced at least 6 syncope episodes since then. The patient sought medical attention by consulting a physician. No treatment was given for the event. The outcome of syncope was reported as not recovered. Causality assessment between the event and GARDASIL 9 was not reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The patient just received a SHINGRIX vaccine on last Thursday, from the date of reporting. After receiving SHINGRIX, the patient was broke out with hives and wanted to know how long she needs to wait to receive a steroid injection. The reporter just wanted to see if there were suggestions on that. The reporter did not have the lot number. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that, another pharmacist gave the patient a dose of SHINGRIX, subcutaneously instead of intramuscular route which led to incorrect route of vaccine administration. The reporter did not provide any other details. He stated he called to ask if the patient needed to be re-vaccinated before he would contact the patient.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of local swelling in a 12-year-old male patient who received FLULAVAL TETRA 2018-2019 season (batch number 4DY9K, expiry date 7th June 2019) for prophylaxis. On 19th September 2018, the patient received FLULAVAL TETRA 2018-2019 season. On 20th September 2018, 1 days after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced local swelling, localized erythema and welts. The patient was treated with BENADRYL. On an unknown date, the outcome of the local swelling, localized erythema and welts were recovered/resolved. It was unknown if the reporter considered the local swelling, localized erythema and welts to be related to FLULAVAL TETRA 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother. After receiving FLULAVAL TETRA, on the next day, the patient developed localized redness and swelling and welts below the vaccination site. The patient's mother reported late on the 20th that inside of 20 minutes the welts disappeared and the redness, swelling were also gone. They never had any respective concerns.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 63-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX. On 22nd September 2018, less than a month after receiving SHINGRIX, the patient experienced fever, shivering, headache and fatigue. On an unknown date, the outcome of the fever and shivering were recovering/resolving and the outcome of the headache and fatigue were not recovered/not resolved. The reporter considered the fever, shivering, headache and fatigue to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever greater than 100 degrees F. The symptoms improved over the course of two days.
Sex: F
Vaccine: FLUR4
Symptoms: Apparent life threatening event, Influenza, Malaise, Medication error, Pyrexia
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 26-Sep-2018 from a consumer. This case involves a 68 years old female patient who experienced she almost died, she got flu, sick as a dog, high fever, she had three seizures, while she received vaccine FLUBLOK QIV. The patients past medical history included Food allergy (eggs). The patients past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Sep-2017, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a serious she almost died (apparent death), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as life-threatening. It was reported that she was down for approximately 6 weeks. On an unknown date, the patient developed a serious three seizures (seizure), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. On 15-Jan-2018, the patient developed a non-serious she got flu (influenza like illness), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious sick as a dog (malaise), high fever (pyrexia) and she had three seizures (seizure), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was she got flu, she had three seizures, high fever, sick as a dog and (Life-threatening) she almost died. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. 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 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. List of documents held by sender: none.; Sender's Comments: This case involves a 68 years old patient who presented with seizures, flu, high fever and near death experience post vaccination with FLUBLOK QIV. Time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab tests and etiological work up ruling out other 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: F
Vaccine: FLUR4
Symptoms: Seizure
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 26-Sep-2018 from a consumer. This case involves a 68 years old female patient who experienced she almost died, she got flu, sick as a dog, high fever, she had three seizures, while she received vaccine FLUBLOK QIV. The patients past medical history included Food allergy (eggs). The patients past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Sep-2017, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a serious she almost died (apparent death), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as life-threatening. It was reported that she was down for approximately 6 weeks. On an unknown date, the patient developed a serious three seizures (seizure), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. On 15-Jan-2018, the patient developed a non-serious she got flu (influenza like illness), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious sick as a dog (malaise), high fever (pyrexia) and she had three seizures (seizure), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was she got flu, she had three seizures, high fever, sick as a dog and (Life-threatening) she almost died. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. 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 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. List of documents held by sender: none.; Sender's Comments: This case involves a 68 years old patient who presented with seizures, flu, high fever and near death experience post vaccination with FLUBLOK QIV. Time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab tests and etiological work up ruling out other 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.