chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Cancer surgery, Hepatitis viral test negative, Lichen planus, Oral lichen planus, Squamous cell carcinoma of skin
Clinical narrative: Initial unsolicited report received from a nurse on 15-Nov-2017 and live follow up was received on 15-Nov-2017. This case involves 53 years old female patient who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date in 2015 or 2016. She received the vaccine at a health fair at a school. The patient's medical history and concomitant medication were not reported. She was allergic to polysporin, sulfites, keflex, latex, morphine and Naprosyn. On an unspecified date, two to three weeks (Also reported as short time after the vaccination) post vaccination she developed lichen planus which was localized to the feet and legs and over time she has had flare ups with it appearing in her mouth. On an unspecified date, approximately two months after appearance of the lichen planus (Also reported as subsequently post vaccination) she developed squamous cell carcinoma (cancer) on her right lower extremity, where an outbreak of the lichen planus had been, and it was removed by a dermatologist. She stated that she was tested for hepatitis and was negative. Corrective treatment was not reported. Patient was not recovered from events. This case was considered as serious by the reporter due to medically significant event. She stated that she believes it was due to the flu vaccine. List of documents held by sender: none; Sender's Comments: The patient experienced lichen planus which was localized to the feet and legs and Squamous Cell carcinoma on her right lower extremity post vaccination with FLUZONE QUADRIVALENT. Time to onset was compatible but the events are not listed with the vaccine. Lichen planus is an autoimmune process and has multiple etiologies. Lichen planus is a benign disorder characterized by an itchy, noninfectious skin rash. Though lichen planus is a common papulosquamous disorder affecting about 1-2% of the population, neoplastic transformation of cutaneous lichen planus lesions occurs very rarely Squamous cell carcinoma might have related etiology with lichen planus. The patient had reported medical history of allergic to polysporin, sulfites, keflex, latex, morphine and naprosyn. Additional information should be obtained regarding evaluation of the events by the physician, treatment information and medical records confirming the diagnosis and its evolution. Based upon the reported information the role fo the vaccine can not be assessed.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Irritability, Teething
Clinical narrative: Received call from ER physician that infant had died. Mom reported child was a little fussy yesterday due to teething. She swaddled him and put him to bed. When she went in to check on him in the middle of the night he had expired.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Injection site erythema, Injection site scab, Injection site swelling, Injection site vesicles
Clinical narrative: Started with bone aches at 9 pm on the 22nd and a blister developed at the injection site with swelling and redness on 23rd till the 25th when the blister disappeared but redness stayed and scabbed. It was still noticeable when I returned to work on Monday the 27th when I reported it to a nurse in PM and showed my employer. I was instructed to have this document completed.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: Extremity numbness and tingling. Facial numbness. Several falls due to loss of sensation in feet.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dyspnoea, Ear disorder, Laboratory test, Malaise
Clinical narrative: Started getting super sick with respiratory issues and ear issues went to dr starting February when it got where I could breathe then every month following was at the doctor's then blood work showing I developed RA.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Respiratory disorder, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Started getting super sick with respiratory issues and ear issues went to dr starting February when it got where I could breathe then every month following was at the doctor's then blood work showing I developed RA.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site ice and ibuprofen
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received FLUARIX Quadrivalent. Concomitant products included sertraline. On 18th October 2017, the patient received FLUARIX Quadrivalent. In November 2017, less than a year after receiving FLUARIX Quadrivalent, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved. The reporter considered the pain in arm and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received concomitant medication Multi vitamin. At first, the patient's arm felt fine but then she experienced severe pain in her left upper arm. Now she was having trouble getting her shirt on an off and the pain had gotten worse. She was also having trouble lifting things. She could not confirm the name of the flu vaccine but her pharmacist referred her to GlaxoSmithKline and Seqirus as the manufacturer based on the date of her vaccination.
Age: 22.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Patient reported on visit for another vaccination, the GARDASIL dose 2, on 11/28/17 that she had a little "bump" where she received the Varicella vaccine on 10/19. Was measured was 2mm under the skin; no change in color and no pain or soreness. Didn't know if it was from vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Influenza like illness, Malaise, Middle insomnia, Ocular hyperaemia
Clinical narrative: Employee received the over 65 flu vaccination on 10/11/17. He was seen in Employee Health on 10/12/2017. Reported having flu-like symptoms and feeling ill after receiving the vaccination.  However, he also reported being woken up in the middle of the night feeling  bilateral eye pain - like razors were in his eyes, and that his vision was impaired. On 10/12/17, at the Employee Health Office his eyes were red with bilateral peri-orbital edema. Employee was examined, no foreign body was noted in either eye. At that time, as vision was still impaired, employee was sent to ED for further evaluation where he was treated and received prescritpions for prednisone, zyrtec, and pepcid. Issues have since been resolved.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Periorbital oedema, Visual impairment
Clinical narrative: Employee received the over 65 flu vaccination on 10/11/17. He was seen in Employee Health on 10/12/2017. Reported having flu-like symptoms and feeling ill after receiving the vaccination.  However, he also reported being woken up in the middle of the night feeling  bilateral eye pain - like razors were in his eyes, and that his vision was impaired. On 10/12/17, at the Employee Health Office his eyes were red with bilateral peri-orbital edema. Employee was examined, no foreign body was noted in either eye. At that time, as vision was still impaired, employee was sent to ED for further evaluation where he was treated and received prescritpions for prednisone, zyrtec, and pepcid. Issues have since been resolved.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Neck pain, Pain, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 59 year old female patient. The patient's concurrent conditions included blood sugar issues and pain from previous injury. The patient's concomitant therapies included FLUCELVAX, alogliptin, levocetirizine dihydrochloride (XYZAL), hydrochlorothiazide, estradiol (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), simvastatin (ZOCOR), lisinopril, gabapentin, metoprolol tartrate, meloxicam (MOBIC) and levocetirizine. On 02-OCT-2017, the patient went to the pharmacy at 4:00 and at 4:09 was vaccinated with the first dose of ZOSTAVAX 19400 PFU at a dose of 0.65 ml / once, subcutaneously back on the right arm,  for the prevention of shingles, lot number N012614 and expiration date of 16-MAR-2018 reconstitued with water sterile diluent (lot number and expiration date were not reported). It was reporter that the day of the vaccination the patient was not on any immunosuppressant therapy, had no illness and was feeling fine. On 04-OCT-2017, reported as two days later or 24 hours after the administration of zoster vaccine live (ZOSTAVAX), the patient developed tenderness, pain, neck pain and rash on her back and flanks. The reporter stated that the patient returned to the pharmacy a week later with a possible rash and redness at the injection site. It was also mentioned, that the patient came into the pharmacy a few days after the vaccination and told about the reaction, the pharmacist returned her with the medical doctor and on a visual inspection he diagnosed her with shingles. Furthermore, the patient received treatment to the aforementioned events. At the time of the report, the outcome of the events shingles, rash and redness at the injection site was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with ZOSTAVAX.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 59 year old female patient. The patient's concurrent conditions included blood sugar issues and pain from previous injury. The patient's concomitant therapies included FLUCELVAX, alogliptin, levocetirizine dihydrochloride (XYZAL), hydrochlorothiazide, estradiol (manufacturer unknown), duloxetine hydrochloride (CYMBALTA), simvastatin (ZOCOR), lisinopril, gabapentin, metoprolol tartrate, meloxicam (MOBIC) and levocetirizine. On 02-OCT-2017, the patient went to the pharmacy at 4:00 and at 4:09 was vaccinated with the first dose of ZOSTAVAX 19400 PFU at a dose of 0.65 ml / once, subcutaneously back on the right arm,  for the prevention of shingles, lot number N012614 and expiration date of 16-MAR-2018 reconstitued with water sterile diluent (lot number and expiration date were not reported). It was reporter that the day of the vaccination the patient was not on any immunosuppressant therapy, had no illness and was feeling fine. On 04-OCT-2017, reported as two days later or 24 hours after the administration of zoster vaccine live (ZOSTAVAX), the patient developed tenderness, pain, neck pain and rash on her back and flanks. The reporter stated that the patient returned to the pharmacy a week later with a possible rash and redness at the injection site. It was also mentioned, that the patient came into the pharmacy a few days after the vaccination and told about the reaction, the pharmacist returned her with the medical doctor and on a visual inspection he diagnosed her with shingles. Furthermore, the patient received treatment to the aforementioned events. At the time of the report, the outcome of the events shingles, rash and redness at the injection site was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with ZOSTAVAX.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report Was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N005619, expiration date on 29-OCT-2019 (strength and dose number were not provided) for prophylaxis, however no adverse effects were reported. The temperature and time frame was: 9°C (Celsius) to 25 °C (8.7°C) for 12 hours and 41 minutes. There was a previous temperature excursion of 0°C to 1°C (0.6°C) for 44 minutes. The call was due to data logger. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA011899:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N005619, expiration date on 29-OCT-2019 (strength and dose number were not provided) for prophylaxis, however no adverse effects were reported. The temperature and time frame was: 9°C (Celsius) to 25 °C (8.7°C) for 12 hours and 41 minutes. There was a previous temperature excursion of 0°C to 1°C (0.6°C) for 44 minutes. The call was due to data logger. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA005489.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Erythema, Headache, Induration
Clinical narrative: 10/03/2017: I received the shingles vaccine along with the flu vaccine in my left arm at my primary care office. 10/04/2017: I noticed a red patch covering about one inch at the injection site of the shingles vaccine. 10/05/2017: The red patch was now raised, had increased to about two inches, indurated, hot to touch, pain and tingling that spread to wrist, blistering present. Phoned physician office and was seen by nurse who believed it to be a reaction to the shingles vaccine. Was advised to watch and report any adverse changes. 10/6/2017: Lesion was about three inches across. Phoned primary care office, spoke with nurse and was advised to continue watching and to seek emergency care if breathing became an issue. 10/10/2017: Noticed a red, indurated, raised, painful to touch lesion on the lateral side of right knee about one inch in diameter. Showed my husband and we believed it to perhaps be a spider bite. 11/01/2017: Traveled to see family. Daughter (age 32 and had chicken pox at age five) informed us she is seven weeks pregnant with first child. 11/02/2017: Notice new lesion on medial side of right knee with same symptoms of the lateral knee lesion (which now looks like a bruise) but is less than one inch in diameter. 11/14/2017: See a physician and he notes that he believes the knee lesions to be a side effect of the shingles vaccine. If lesion is still present in two weeks a cortisone injection may be warranted. 11/21/2017: A new lesion is on right arm, halfway between elbow and wrist on the lateral side. Symptoms consistent with knee lesions and is a little over one inch in diameter. I have been experiencing generalized joint pain that I thought was related to the change in temperatures as the season goes from autumn to winter. I have also noticed an increase in headaches. I have been taking ibuprofen as needed for pain and do not require anything stronger. Mediations: Atenolol 25 mg daily for high blood pressure, Fluticasone Propionate nasal spray as needed, BENADRYL as needed. Allergies: Latex, sulfa drugs, gluten and dairy intolerant.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: 10/03/2017: I received the shingles vaccine along with the flu vaccine in my left arm at my primary care office. 10/04/2017: I noticed a red patch covering about one inch at the injection site of the shingles vaccine. 10/05/2017: The red patch was now raised, had increased to about two inches, indurated, hot to touch, pain and tingling that spread to wrist, blistering present. Phoned physician office and was seen by nurse who believed it to be a reaction to the shingles vaccine. Was advised to watch and report any adverse changes. 10/6/2017: Lesion was about three inches across. Phoned primary care office, spoke with nurse and was advised to continue watching and to seek emergency care if breathing became an issue. 10/10/2017: Noticed a red, indurated, raised, painful to touch lesion on the lateral side of right knee about one inch in diameter. Showed my husband and we believed it to perhaps be a spider bite. 11/01/2017: Traveled to see family. Daughter (age 32 and had chicken pox at age five) informed us she is seven weeks pregnant with first child. 11/02/2017: Notice new lesion on medial side of right knee with same symptoms of the lateral knee lesion (which now looks like a bruise) but is less than one inch in diameter. 11/14/2017: See a physician and he notes that he believes the knee lesions to be a side effect of the shingles vaccine. If lesion is still present in two weeks a cortisone injection may be warranted. 11/21/2017: A new lesion is on right arm, halfway between elbow and wrist on the lateral side. Symptoms consistent with knee lesions and is a little over one inch in diameter. I have been experiencing generalized joint pain that I thought was related to the change in temperatures as the season goes from autumn to winter. I have also noticed an increase in headaches. I have been taking ibuprofen as needed for pain and do not require anything stronger. Mediations: Atenolol 25 mg daily for high blood pressure, Fluticasone Propionate nasal spray as needed, BENADRYL as needed. Allergies: Latex, sulfa drugs, gluten and dairy intolerant.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Paraesthesia, Peripheral swelling, Skin lesion
Clinical narrative: 10/03/2017: I received the shingles vaccine along with the flu vaccine in my left arm at my primary care office. 10/04/2017: I noticed a red patch covering about one inch at the injection site of the shingles vaccine. 10/05/2017: The red patch was now raised, had increased to about two inches, indurated, hot to touch, pain and tingling that spread to wrist, blistering present. Phoned physician office and was seen by nurse who believed it to be a reaction to the shingles vaccine. Was advised to watch and report any adverse changes. 10/6/2017: Lesion was about three inches across. Phoned primary care office, spoke with nurse and was advised to continue watching and to seek emergency care if breathing became an issue. 10/10/2017: Noticed a red, indurated, raised, painful to touch lesion on the lateral side of right knee about one inch in diameter. Showed my husband and we believed it to perhaps be a spider bite. 11/01/2017: Traveled to see family. Daughter (age 32 and had chicken pox at age five) informed us she is seven weeks pregnant with first child. 11/02/2017: Notice new lesion on medial side of right knee with same symptoms of the lateral knee lesion (which now looks like a bruise) but is less than one inch in diameter. 11/14/2017: See a physician and he notes that he believes the knee lesions to be a side effect of the shingles vaccine. If lesion is still present in two weeks a cortisone injection may be warranted. 11/21/2017: A new lesion is on right arm, halfway between elbow and wrist on the lateral side. Symptoms consistent with knee lesions and is a little over one inch in diameter. I have been experiencing generalized joint pain that I thought was related to the change in temperatures as the season goes from autumn to winter. I have also noticed an increase in headaches. I have been taking ibuprofen as needed for pain and do not require anything stronger. Mediations: Atenolol 25 mg daily for high blood pressure, Fluticasone Propionate nasal spray as needed, BENADRYL as needed. Allergies: Latex, sulfa drugs, gluten and dairy intolerant.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: 10/03/2017: I received the shingles vaccine along with the flu vaccine in my left arm at my primary care office. 10/04/2017: I noticed a red patch covering about one inch at the injection site of the shingles vaccine. 10/05/2017: The red patch was now raised, had increased to about two inches, indurated, hot to touch, pain and tingling that spread to wrist, blistering present. Phoned physician office and was seen by nurse who believed it to be a reaction to the shingles vaccine. Was advised to watch and report any adverse changes. 10/6/2017: Lesion was about three inches across. Phoned primary care office, spoke with nurse and was advised to continue watching and to seek emergency care if breathing became an issue. 10/10/2017: Noticed a red, indurated, raised, painful to touch lesion on the lateral side of right knee about one inch in diameter. Showed my husband and we believed it to perhaps be a spider bite. 11/01/2017: Traveled to see family. Daughter (age 32 and had chicken pox at age five) informed us she is seven weeks pregnant with first child. 11/02/2017: Notice new lesion on medial side of right knee with same symptoms of the lateral knee lesion (which now looks like a bruise) but is less than one inch in diameter. 11/14/2017: See a physician and he notes that he believes the knee lesions to be a side effect of the shingles vaccine. If lesion is still present in two weeks a cortisone injection may be warranted. 11/21/2017: A new lesion is on right arm, halfway between elbow and wrist on the lateral side. Symptoms consistent with knee lesions and is a little over one inch in diameter. I have been experiencing generalized joint pain that I thought was related to the change in temperatures as the season goes from autumn to winter. I have also noticed an increase in headaches. I have been taking ibuprofen as needed for pain and do not require anything stronger. Mediations: Atenolol 25 mg daily for high blood pressure, Fluticasone Propionate nasal spray as needed, BENADRYL as needed. Allergies: Latex, sulfa drugs, gluten and dairy intolerant.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pyrexia, Tremor
Clinical narrative: The following symptoms occurred, starting 3 and one half hours after receiving flu shot: General malaise, Shaking chills, Fever to 101.8 degrees F. After taking CLARITIN, 2 ALEVE, and 2 ADVIL, fever subsided to low grade. General malaise continued for 24 hours.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Developed a rash -- some bumps in a stripe pattern--a few d after vaccination. Does not bother her.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Bright red, swollen all the way down to elbow.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Ageusia, Asthenia, Blepharospasm, Depressed level of consciousness, Facial paralysis
Clinical narrative: I get severe headaches, my body has lost energy, I felt that my leg, arm and hand muscles were weakened, along with the feeling of numbness on my right eye spasms all the time and I cannot see clearly. My vision is blurry and cloudy, strong ringing sounds in my right ear, gradually I felt that my tongue lost sensitivity to feel the food making it harder to chew as well as loss of taste. I felt that my tongue got difficult to move, I started to make noises with my mouth. Now I have terrible migraines daily and a dramatic decrease with alertness and energy.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Mastication disorder, Migraine
Clinical narrative: I get severe headaches, my body has lost energy, I felt that my leg, arm and hand muscles were weakened, along with the feeling of numbness on my right eye spasms all the time and I cannot see clearly. My vision is blurry and cloudy, strong ringing sounds in my right ear, gradually I felt that my tongue lost sensitivity to feel the food making it harder to chew as well as loss of taste. I felt that my tongue got difficult to move, I started to make noises with my mouth. Now I have terrible migraines daily and a dramatic decrease with alertness and energy.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Tinnitus, Tongue movement disturbance, Vision blurred
Clinical narrative: I get severe headaches, my body has lost energy, I felt that my leg, arm and hand muscles were weakened, along with the feeling of numbness on my right eye spasms all the time and I cannot see clearly. My vision is blurry and cloudy, strong ringing sounds in my right ear, gradually I felt that my tongue lost sensitivity to feel the food making it harder to chew as well as loss of taste. I felt that my tongue got difficult to move, I started to make noises with my mouth. Now I have terrible migraines daily and a dramatic decrease with alertness and energy.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphonia, Mastication disorder, Nasal congestion, Oral pain
Clinical narrative: Several days after receiving the immunization, the patient called the pharmacy complaining of arm pain and jaw pain. She explained that she could barely chew her food or flip a light switch because the pain was so severe. We advised the patient to contact her physician for an examination. The patient was seen by her primary physician, who stated there was nothing imminently wrong, but it may have been a result of the flu shot administration or that her jaw pain may be from the patient tensing up on the side that she received the shot. The patient called back two weeks after receiving the shot still complaining of mouth and arm pain, but now is experiencing chills, nasal congestion, and a raspy voice.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Pain in jaw
Clinical narrative: Several days after receiving the immunization, the patient called the pharmacy complaining of arm pain and jaw pain. She explained that she could barely chew her food or flip a light switch because the pain was so severe. We advised the patient to contact her physician for an examination. The patient was seen by her primary physician, who stated there was nothing imminently wrong, but it may have been a result of the flu shot administration or that her jaw pain may be from the patient tensing up on the side that she received the shot. The patient called back two weeks after receiving the shot still complaining of mouth and arm pain, but now is experiencing chills, nasal congestion, and a raspy voice.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: Urticaria, wheezing and coughing.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Urticaria, wheezing and coughing.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Oral mucosal blistering, Pain, Pyrexia, Urticaria
Clinical narrative: BLISTERS ON INSIDE OF MOUTH, RED WELTS ON FACE, FEVER AND ACHES.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient complained of radiating pain from shoulder to hand starting 24 hours after shot. Patient had prednisone and took some which did provide relief. Pt visited md on 11/28/2017 and was issued a new script to continue prednisone. No diagnosis given but patient did say pain could also be related to some type of autoimmune disorder she has. Pt also stated, she felt shot was given more towards the tricep area.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Acute kidney injury, Blood creatinine increased, Blood pH decreased, Blood sodium increased, Continuous positive airway pressure
Clinical narrative: The patient received the vaccine in our clinic on 11/22/17 then on the drive home, he began having difficulty breathing and lethargy. He was taken to a fire station who bagged him then he was transported to Hospital where he was placed on CPAP because his blood gas returned with a PH 7.1 and an elevated PCO2 in the 90s. He received IVFs and antibiotics and was admitted to the PICU. He was eventually intubated/ventilated for 2 days. He was temporarily on IV epinephrine due to low blood pressure the day after the vaccine. He had acute kidney injury (creatinine doubled) 2 days after he received the vaccine and an elevated sodium to 166. This improved with free water. He continues to be hospitalized 7 days after vaccination due to electrolyte abnormalities but he at his baseline respiratory, cardiovascular, and mental status. The diagnoses in his hospital chart include sepsis and aspiration pneumonia but he was at his baseline health without signs of acute illness when he received the influenza vaccine.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Electrolyte imbalance, Endotracheal intubation, Hypotension, Intensive care
Clinical narrative: The patient received the vaccine in our clinic on 11/22/17 then on the drive home, he began having difficulty breathing and lethargy. He was taken to a fire station who bagged him then he was transported to Hospital where he was placed on CPAP because his blood gas returned with a PH 7.1 and an elevated PCO2 in the 90s. He received IVFs and antibiotics and was admitted to the PICU. He was eventually intubated/ventilated for 2 days. He was temporarily on IV epinephrine due to low blood pressure the day after the vaccine. He had acute kidney injury (creatinine doubled) 2 days after he received the vaccine and an elevated sodium to 166. This improved with free water. He continues to be hospitalized 7 days after vaccination due to electrolyte abnormalities but he at his baseline respiratory, cardiovascular, and mental status. The diagnoses in his hospital chart include sepsis and aspiration pneumonia but he was at his baseline health without signs of acute illness when he received the influenza vaccine.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Mechanical ventilation, PCO2 increased, Pneumonia aspiration, Sepsis
Clinical narrative: The patient received the vaccine in our clinic on 11/22/17 then on the drive home, he began having difficulty breathing and lethargy. He was taken to a fire station who bagged him then he was transported to Hospital where he was placed on CPAP because his blood gas returned with a PH 7.1 and an elevated PCO2 in the 90s. He received IVFs and antibiotics and was admitted to the PICU. He was eventually intubated/ventilated for 2 days. He was temporarily on IV epinephrine due to low blood pressure the day after the vaccine. He had acute kidney injury (creatinine doubled) 2 days after he received the vaccine and an elevated sodium to 166. This improved with free water. He continues to be hospitalized 7 days after vaccination due to electrolyte abnormalities but he at his baseline respiratory, cardiovascular, and mental status. The diagnoses in his hospital chart include sepsis and aspiration pneumonia but he was at his baseline health without signs of acute illness when he received the influenza vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Injection site reaction, Pain, Peripheral swelling, Rash
Clinical narrative: Rash covering one third of arm and raised patch of swelled tissue covering one third of arm. Reaction extended from site of injection in upper arm to below elbow and lasted for one week duration. Severe pain when lifting arm also lasted for one week duration. Rash on chest for one day duration mid-adverse reaction incident time period. Missed some work hours due to pain.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Inflammation, Injection site infection, Injection site swelling, Pain, Pyrexia
Clinical narrative: Within 6 hours of immunizations on 11/18/17, patient developed severe pain, inflammation, and a high fever (102 F). These did not go away, but only got worse so patient went to her Dr on 11/21/17 and was told he suspected infection at injection site. She was started on Cephalexin 500mg. She reported incident to the pharmacy on 11/27/17 and mentioned it was the first time since the immunizations that she felt well enough to come to the pharmacy. She showed a picture of her arm to me and I could see that swelling appeared to be below where the injection sites would have been.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site erythema, Injection site swelling, Nausea, Rash
Clinical narrative: Patient came to the Health Dept on 10/06/17 and spoke to RN regarding a mild redness and swelling at the injection site. She was told by the nurse that is a common local reaction to the pneumonia vaccine and to alternate cool and warm compresses. RN states that she called her on that following Monday and the patient reported that she was fine. On 11/2/17, Health Director reports to me that patient came by and complains of a nausea and vomiting, cough, rash to the left leg, unable to lay on left arm and has redness at the site.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Patient came to the Health Dept on 10/06/17 and spoke to RN regarding a mild redness and swelling at the injection site. She was told by the nurse that is a common local reaction to the pneumonia vaccine and to alternate cool and warm compresses. RN states that she called her on that following Monday and the patient reported that she was fine. On 11/2/17, Health Director reports to me that patient came by and complains of a nausea and vomiting, cough, rash to the left leg, unable to lay on left arm and has redness at the site.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Measles-like rash, starting on head / face, moving caudally. Began on day 10 after vaccines. Worsened overnight from day 10 to 11. Supportive care.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes.  The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same report.; Sender's Comments: US-009507513-1711USA002012:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes.  The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same report.; Sender's Comments:  US-009507513-1711USA002012:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 73 years old male patient who was referring to himself. The patient did not have any drug reactions or allergies. The patient's medical history included herpes zoster on an unknown date (reported as "in [his] 30s"). On an unknown date in 2015 (reported as about two years ago), the patient was vaccinated with ZOSTAVAX injection (dose, lot # and expiry date were not provided). Concomitant therapies included tamsulosin hydrochloride and atorvastatin. On an unknown date in 2017 (reported as "just recently"), the patient developed shingles. Unspecified treatment was given for the event. The outcome of shingles was reported as not recovered. The causality assessment was not provided.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13 Lot Number S43277, Expiry Date 30Sep2019, intramuscular on 02Oct2017 15:00 at 0.5ml, intramuscularly, in Deltoid Left for immunisation. The patient medical history was none. No additional vaccines were administered on same date. The patient's concomitant medications were not reported. The patient experienced whole arm hurt and it was hard to lift from 02Oct2017 15:15 which was assessed as medically significant as per the reporter with outcome of not recovered. The patient was not seen by a physician regarding this. The pharmacist does not feel that it was the fault of the medication, but believed that it was administered improperly, either too high or too low. Sender's Comments: Whole arm hurt and hard to lift on the vaccinated limb are more likely associated with the wrongly administered site resulting from the improper technique in vaccination process; in the meantime, vaccination site pain and limb mobility decreased are the known adverse event risk for the suspect vaccine.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Adverse drug reaction, Chest X-ray abnormal, Death, Diarrhoea, Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Dyspnoea, Hospice care, Nausea, Pneumococcal bacteraemia, Pneumococcal sepsis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Pneumonia pneumococcal, Pyrexia, Streptococcus test positive, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Abdominal pain, Acute kidney injury, Acute respiratory failure, Agitation, Apnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Bilevel positive airway pressure, Chest X-ray abnormal, Communication disorder, Cough, Death
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.