chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 16-JAN-2019, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB second dose, intramuscularly in the right upper thigh lot number R013572. Other suspect therapies included PEDIARIX second dose, intramuscularly, in the left mid thigh, lot number XT73A, PREVNAR 13 second dose, intramuscularly, in the left lower thigh, lot number W33490 and ROTARIX second dose, orally, lot number 7Y2YE all of them for prophylaxis (expiration date was not provided). No adverse events reactions thus no treatment was prescribed. Data logger was involved.  The vaccine was exposed to a temperature excursion in the refrigerator below 2°C. The reporter stated that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA002414: US-009507513-1902USA002412: US-009507513-1901USA011370.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 26-OCT-2018, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB first dose, intramuscular in the left vastus lateralis lot number R004964. Other suspect therapies included PEDIARIX first dose, intramuscularly, in the left vastus lateralis, lot number 9A2KC, PREVNAR 13 first dose, intramuscularly, in the right vastus lateralis, lot number W11304 and ROTARIX first dose, orally, lot number 557R9 all of them for prophylaxis (expiration date was not provided). No adverse events reactions thus no treatment was prescribed. Data logger was involved. The vaccine was exposed to a temperature excursion in the refrigerator below 2°C. The reporter stated that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter.  Sender's Comments: US-009507513-1901USA011370: US-009507513-1902USA002412: US-009507513-1902USA002413.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis, Herpes zoster, Insomnia, Pain of skin, Rash
Clinical narrative: Information has been received from the authors in a published literature article, title below, regarding a 20 month old male child. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 13 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right thigh for prophylaxis. He was symptom free until he developed a rash 7 months later. The rash was beefy red, vesicular, and localized to his right thigh and lower back, mainly along dermatome L3. He was examined twice in the outpatient clinic. No neurologic deficits were apparent either time. The exanthem worsened for 1 week, then slowly cleared over the following 2 weeks. The inflamed skin appeared to be painful, since the child avoided sleeping on that side. He was not admitted to the hospital nor was he treated with acyclovir and the patient was diagnosed with herpes zoster (shingles). Because of the severity of his rash, serology studies were performed to measure Varicella zoster virus (VZV) antibody and he was positive for both IgM (more than 1:64) and IgG (more than 1:256) by the fluorescent antibody to antigen assay. The exanthem worsened for 1 week, then slowly cleared over the following 2 weeks on an unspecified date. The author considered the events to be related to the suspect therapy. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1901USA011678.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular, Varicella virus test positive
Clinical narrative: Information has been received from the authors in a published literature article, title below, regarding a 20 month old male child. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 13 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right thigh for prophylaxis. He was symptom free until he developed a rash 7 months later. The rash was beefy red, vesicular, and localized to his right thigh and lower back, mainly along dermatome L3. He was examined twice in the outpatient clinic. No neurologic deficits were apparent either time. The exanthem worsened for 1 week, then slowly cleared over the following 2 weeks. The inflamed skin appeared to be painful, since the child avoided sleeping on that side. He was not admitted to the hospital nor was he treated with acyclovir and the patient was diagnosed with herpes zoster (shingles). Because of the severity of his rash, serology studies were performed to measure Varicella zoster virus (VZV) antibody and he was positive for both IgM (more than 1:64) and IgG (more than 1:256) by the fluorescent antibody to antigen assay. The exanthem worsened for 1 week, then slowly cleared over the following 2 weeks on an unspecified date. The author considered the events to be related to the suspect therapy. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1901USA011678.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: Information has been received from the authors in a published literature article, title below, regarding a 3 year old male infant. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 1 year, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right thigh for prophylaxis. On unknown date, at the age of 3.5 years, the patient experienced a severe rash in the right thigh and lower back, mainly along dermatome L3 and diagnosed with herpes zoster (shingles). She patient was recovered on an unspecified date. The author considered the events to be related to the suspect therapy. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1901USA011678.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A female patient of unspecified age (reported as over age 65) received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder and arm swelling, redness, pain after use of product on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness, Ear discomfort
Clinical narrative: Loss of hearing, feeling of pressure in one or both ears depending on day, somewhat like when flying and ears need to pop but won't. Caused my balance to be off and if there was any background noise I can't hear what people are saying. Still happening but not as bad and sometimes it seems to have cleared up. My doctor suggested using MUCINEX and FLONASE but they didn't seem to make much difference.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MNQ, TDAP
Symptoms: Blood glucose normal, Confusional state, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Immediately after receiving vaccines, patient put his head down, stiffened up and had syncopal episode. + loss of consciousness for a few seconds. Was confused after it happened. He laid down for 10 minutes and after that he sat up and was initially feeling better. 5 minutes after sitting up, he had a second syncopal episode where his head went back, he went stiff and then started falling towards the side. + loss of consciousness for a few seconds again. Vital signs at this time were BP 132/63, HR 51, O2 sat 99% in room air. 911 was called. Ambulance arrived within 5 min. Next set of vitals at 1004: BP 112/57, HR 61, O2 sat 99% in room air. Repeat at 1020: BP 115/77, HR 68. Pt continued to be alert and oriented, answering questions appropriately. Mild pallor. MDs and ambulance staff advised that patient be taken to the ER for further evaluation but family refused. Family did not give reason for refusal; only stated that they thought he "just needed to get home and eat something." Family was informed that ER visit should be covered by emergency insurance if no other insurance available. Ambulance staff called their supervisor, who also spoke to the family. Family still refused and signed form from ambulance staff stating their refusal. Pt remained seated, alert and oriented during conversation. Pt then walked without assistance out of the mobile clinic and into family's private vehicle.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Immediately after receiving vaccines, patient put his head down, stiffened up and had syncopal episode. + loss of consciousness for a few seconds. Was confused after it happened. He laid down for 10 minutes and after that he sat up and was initially feeling better. 5 minutes after sitting up, he had a second syncopal episode where his head went back, he went stiff and then started falling towards the side. + loss of consciousness for a few seconds again. Vital signs at this time were BP 132/63, HR 51, O2 sat 99% in room air. 911 was called. Ambulance arrived within 5 min. Next set of vitals at 1004: BP 112/57, HR 61, O2 sat 99% in room air. Repeat at 1020: BP 115/77, HR 68. Pt continued to be alert and oriented, answering questions appropriately. Mild pallor. MDs and ambulance staff advised that patient be taken to the ER for further evaluation but family refused. Family did not give reason for refusal; only stated that they thought he "just needed to get home and eat something." Family was informed that ER visit should be covered by emergency insurance if no other insurance available. Ambulance staff called their supervisor, who also spoke to the family. Family still refused and signed form from ambulance staff stating their refusal. Pt remained seated, alert and oriented during conversation. Pt then walked without assistance out of the mobile clinic and into family's private vehicle.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: Pain at site of injection. Extreme fatigue. Stiffness. Slept from 8 pm until 5 p.m. the next day. Unable to do any activities during that time.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Vomiting
Clinical narrative: Crying inconsolable x 2 hrs. vomited 3 times.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. reported to Immunization clinic today and showed her left upper arm with redness and swollen, advised pt. to apply cold compress and take OTC medication like TYLENOL or MOTRIN. Advised pt. to go to ER if the symptoms gets worst or she will experience SOB or any tightness on her throat. Pt. will call back the clinic if she have any question or concern.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Muscle spasms, Nausea, Pain, Peripheral swelling, Vomiting
Clinical narrative: Pt called on 12/28/18 reporting an adverse reaction to her PREVNAR and flu vaccines. She reports at 6pm on 12/27/18, her left arm started to swell and she started having nausea and vomiting and leg cramps. She used ice packs and swelling has gone down. Denied any shortness of breath, throat or mouth swelling. Still was complaining of body aches.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Headache, Tremor
Clinical narrative: Headache, extreme tremors, unable to walk.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Tremor
Clinical narrative: Headache, severe chills with body shaking, body aches, extreme fatigue.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The whole upper arm swell. The swelling went down toward the inner elbow, it is red and painful.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Dizziness, Eye movement disorder, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Pt immediately stated that she felt "funny" --I asked if she was lightheaded or dizzy and she said yes. I sent my tech to get her some orange juice as I felt it might be low sugar. As I turned back around, the patient's arm started twitching and her head lolled to the side. Her eyes rolled into her head and her mouth hung open. She was unresponsive to both verbal and physical stimulation. I called to my intern to dial 911 and returned my attention to the patient. At this time, she suddenly opened her eyes and was able to speak to me candidly, though she had no recollection of the incident. I still had medical personnel come to check her vitals. It was determined that patient had low blood sugar at the time of the incident. She will follow up with her doctor to retest labs. Pt fine after eating and resting. Follow up phone call 3 hours later found patient well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pt immediately stated that she felt "funny" --I asked if she was lightheaded or dizzy and she said yes. I sent my tech to get her some orange juice as I felt it might be low sugar. As I turned back around, the patient's arm started twitching and her head lolled to the side. Her eyes rolled into her head and her mouth hung open. She was unresponsive to both verbal and physical stimulation. I called to my intern to dial 911 and returned my attention to the patient. At this time, she suddenly opened her eyes and was able to speak to me candidly, though she had no recollection of the incident. I still had medical personnel come to check her vitals. It was determined that patient had low blood sugar at the time of the incident. She will follow up with her doctor to retest labs. Pt fine after eating and resting. Follow up phone call 3 hours later found patient well.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Confusional state, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: Really severe headache with intense sharp pain for over 3 days when he never had a migraine before, forgetfulness/confusion, soreness, tired, not feeling well, congestion, sinus drainage, felt like his brain was swollen and inflamed, sensitivity to light, lack of appetite, coughing up mucus.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Malaise, Memory impairment, Pain, Paranasal sinus hypersecretion, Photophobia
Clinical narrative: Really severe headache with intense sharp pain for over 3 days when he never had a migraine before, forgetfulness/confusion, soreness, tired, not feeling well, congestion, sinus drainage, felt like his brain was swollen and inflamed, sensitivity to light, lack of appetite, coughing up mucus.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Productive cough, Respiratory tract congestion
Clinical narrative: Really severe headache with intense sharp pain for over 3 days when he never had a migraine before, forgetfulness/confusion, soreness, tired, not feeling well, congestion, sinus drainage, felt like his brain was swollen and inflamed, sensitivity to light, lack of appetite, coughing up mucus.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This is one of several patients in the last couple months that have had local reaction (redness, hot to touch, swelling, pain) when these two vaccines are administered in the same location on same day.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, and swelling at injection site. Ice used on site and Ibuprofen 600mg taken.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: Immediate pain at site of injection x 36+ hours. Shivers beginning 12 hours post injection followed by severe myalgias, sweats, possible fever (I did not check). SX improved 36 hours post injection and resolved 60 hours post injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives, urticaria, still having random flare ups off and on.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hyperhidrosis, Malaise, Pain, Tremor
Clinical narrative: Patient came through the drive thru complaining of soreness and sweating/shaking. Patient said she felt like she was getting sick. I asked if she had diabetes, asthma/COPD, and tried to screen for why we gave the pneumonia vaccine. Patient said she was around someone else who had pneumonia. This patient does not have any conditions qualifying her for the vaccine and we broke protocol administering it.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: The injection site is very sore, tender, and swollen. Large area (6-7 inches in diameter) around the injection site also turned red. She also became febrile for which she took acetaminophen. Patient has been taking BENADRYL since the symptoms appeared the night of the injection. She then visited her primary care doctor on the 7th of Feb. She was then prescribed amoxicillin (500mg) to prevent possible infection at the injection site. It has been over 40 hours since the symptoms first appeared. Patient continues to experience to adverse reaction to the vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Patient said on the day she got PNEUMOVAX she was fine, however, the next day her arm where she got the injection had swollen up and felt hard when she touched it. Pharmacist advised her to ice it and take OTC pain med. On the third day patient called and said the fluid that was causing the swell went down to her elbow area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Disturbance in attention, Fatigue, Feeding disorder
Clinical narrative: Raised and Soreness at the injection site for a couple of days. Patient usually not with this reaction following vaccines. In addition, approximately 12 hours after the injection, the patient experienced severe rigors and shivering waking her from sleep. The reaction was so severe that she was unable to go back to sleep. This lasted for at least 8 hours. This was then followed by severe fatigue, myalgia, arthralgia, and nausea. She was unable drive, pay attention, or eat until later that evening. She was so fatigued that she had to miss a day of work.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Impaired work ability, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Raised and Soreness at the injection site for a couple of days. Patient usually not with this reaction following vaccines. In addition, approximately 12 hours after the injection, the patient experienced severe rigors and shivering waking her from sleep. The reaction was so severe that she was unable to go back to sleep. This lasted for at least 8 hours. This was then followed by severe fatigue, myalgia, arthralgia, and nausea. She was unable drive, pay attention, or eat until later that evening. She was so fatigued that she had to miss a day of work.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Sleep disorder
Clinical narrative: Raised and Soreness at the injection site for a couple of days. Patient usually not with this reaction following vaccines. In addition, approximately 12 hours after the injection, the patient experienced severe rigors and shivering waking her from sleep. The reaction was so severe that she was unable to go back to sleep. This lasted for at least 8 hours. This was then followed by severe fatigue, myalgia, arthralgia, and nausea. She was unable drive, pay attention, or eat until later that evening. She was so fatigued that she had to miss a day of work.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, red, swollen arm at vaccine injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Confusional state, Hyperhidrosis, Muscular weakness
Clinical narrative: Muscle weakness, 101.9 temp (normal temp 97.4), severe sweating, confusion.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury, Pain in extremity, Vaccination complication
Clinical narrative: SIRVA - patient is complaining of pain in upper arm after the immunization and has seen her doctor. The pain has persisted for 3 months now and has gone to her fingers. She has been referred to a specialist.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Injection site erythema, Pruritus, Rash
Clinical narrative: He has a spreading, nonitchy blanching urticaria / morbiliform rash on his upper body after receiving a shingles vaccine yesterday morning and amoxicillin for a root canal on Monday. The rash was located on the left arm, right arm flexural surface, neck, left midaxillary area just posterior to the spleen, and anterior bilateral ribcage area. It is tender to palpation on the left upper extremity. He first noticed a 5 x 5 cm expanse of redness on his left arm a few cm below where his shot was administered this morning. This has now expanded to include the rest of his arm above his left neck and then parts of his right arm, chest, as well as back. It is beginning to become itchy on his back. The focus on his left arm is tender at rest and with palpation, 3 to 6 out of 10. His lower extremities or mucosal surfaces do not have the rash. He has received the ZOSTAVAX vaccine before without any issues. He also had taken amoxicillin several times many years back without any issues. He endorses feeling colder since yesterday, but otherwise denies any systemic symptoms including shortness of breath, throat pain, headache, vision changes, muscular pain, joint pain, fever, abdominal pain, hematuria, or bowel changes. He has never had any skin rashes before this.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash morbilliform, Tenderness, Urticaria
Clinical narrative: He has a spreading, nonitchy blanching urticaria / morbiliform rash on his upper body after receiving a shingles vaccine yesterday morning and amoxicillin for a root canal on Monday. The rash was located on the left arm, right arm flexural surface, neck, left midaxillary area just posterior to the spleen, and anterior bilateral ribcage area. It is tender to palpation on the left upper extremity. He first noticed a 5 x 5 cm expanse of redness on his left arm a few cm below where his shot was administered this morning. This has now expanded to include the rest of his arm above his left neck and then parts of his right arm, chest, as well as back. It is beginning to become itchy on his back. The focus on his left arm is tender at rest and with palpation, 3 to 6 out of 10. His lower extremities or mucosal surfaces do not have the rash. He has received the ZOSTAVAX vaccine before without any issues. He also had taken amoxicillin several times many years back without any issues. He endorses feeling colder since yesterday, but otherwise denies any systemic symptoms including shortness of breath, throat pain, headache, vision changes, muscular pain, joint pain, fever, abdominal pain, hematuria, or bowel changes. He has never had any skin rashes before this.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Anxiety, Cough, Dyspnoea, Feeling abnormal, Injection site pain
Clinical narrative: At 5pm, patient began to clear throat repeatedly. Water did not help. She also skipped dinner due to feeling poorly. She was given TYLENOL at 2000 because of complaints of a sore injection site. She was asleep by 8:30 and woke up at midnight with a fever of 102.4. She was complaining of "I can't breath" and speaking with chopping words. She would not lay down and was very anxious requiring a light to be on. She repeatedly stated, "I can't catch my breathe". After discussion with nurse line, we were instructed to go to ER. Cold night air improved breathing and by the time the ER was reached, she only had a dry cough and had calmed considerably. Fever continues into next day noted to be between 102 and 103 throughout the day with no further episodes of shortness of breath.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Speech disorder, Throat irritation
Clinical narrative: At 5pm, patient began to clear throat repeatedly. Water did not help. She also skipped dinner due to feeling poorly. She was given TYLENOL at 2000 because of complaints of a sore injection site. She was asleep by 8:30 and woke up at midnight with a fever of 102.4. She was complaining of "I can't breath" and speaking with chopping words. She would not lay down and was very anxious requiring a light to be on. She repeatedly stated, "I can't catch my breathe". After discussion with nurse line, we were instructed to go to ER. Cold night air improved breathing and by the time the ER was reached, she only had a dry cough and had calmed considerably. Fever continues into next day noted to be between 102 and 103 throughout the day with no further episodes of shortness of breath.
Age: 0.08
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient mother and father was called and informed about what happen. Per mother patient had no reaction to vaccines. Patient is schedule for skin integrity check for 02/08/2019 with doctor.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Cardiomegaly, Electrocardiogram, Feeling abnormal, Gastrooesophageal reflux disease, Hypertension
Clinical narrative: Affected the central nervous system first. Enlarged heart and esophagus. Sleep apnea. I thought I was having heart attacks. Onset of GERD and peptic ulcer disease w/high blood pressure and racing heart. Treatment: EKG, esophagus and stomach scoped. Given medications VALIUM and blood pressure meds. ZANTAC. I am disabled. I was never as sick as I have been since the non FDA approved Anthrax shots. How could government allow us to take non FDA approved medications? Shame on them.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Nervous system disorder, Oesophageal achalasia, Oesophagogastroscopy abnormal, Palpitations, Peptic ulcer
Clinical narrative: Affected the central nervous system first. Enlarged heart and esophagus. Sleep apnea. I thought I was having heart attacks. Onset of GERD and peptic ulcer disease w/high blood pressure and racing heart. Treatment: EKG, esophagus and stomach scoped. Given medications VALIUM and blood pressure meds. ZANTAC. I am disabled. I was never as sick as I have been since the non FDA approved Anthrax shots. How could government allow us to take non FDA approved medications? Shame on them.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep apnoea syndrome
Clinical narrative: Affected the central nervous system first. Enlarged heart and esophagus. Sleep apnea. I thought I was having heart attacks. Onset of GERD and peptic ulcer disease w/high blood pressure and racing heart. Treatment: EKG, esophagus and stomach scoped. Given medications VALIUM and blood pressure meds. ZANTAC. I am disabled. I was never as sick as I have been since the non FDA approved Anthrax shots. How could government allow us to take non FDA approved medications? Shame on them.
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose of state FLUZONE given. 0.5 ml of state FLUZONE given, instead of 0.25 mL.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Patient sitting upright on exam room bed 4:10p. 4:11p after pt received HPV vaccine at 4:10p pt went backward on bed, lips and face pale, pt alert, eyes following nurse and open, P=60, B/P=88/60 at 4:12p. Doctor instructed pt to lay down on bed. 4:19p = pt color returning. 4:35p B/P 92/68, P-68, pt talking to family members states he feels fine. 4:44p = B/P 98/62, P-72, pt discharged. Responsive, no LOC.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Positive 8cm area of erythema.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever after vaccination and vomiting (mother believes due to cyclic vomiting).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Pyrexia
Clinical narrative: Fever after vaccination also had chills by description though mother felt were seizure.
Age: 87.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Please call patient for specific details including time of vaccination/place administered/etc.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Fungal test, Gram stain, Incisional drainage, Injection site erythema, Injection site pain
Clinical narrative: Patient is a 49-year-old male who presents for evaluation of left arm injection site reaction. Patient states he had hepatitis A vaccination injection in his proximal left upper extremity on 10/3/18. Patient states about 3 weeks following injection he noticed redness and swelling of the proximal left upper extremity near injection site. Patient states the area was sore and swollen. States any other end of October/beginning of November the area on his proximal left upper extremity was lanced. Reports the area draining a large amount of yellow drainage at that time. States he was also put on antibiotics. Patient reports the area to the long time to heal and never completely healed. Reports S scab would appear, he would wash it off, and it would grow back. States the area on his proximal left upper extremity opened up about 1 week ago. Reports erythema. Rates pain 1/10. Denies fever, sweats, chills. I and D performed, cultures obtained, WTD dsg BID.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling, Mycobacterium test, Purulence, Scab
Clinical narrative: Patient is a 49-year-old male who presents for evaluation of left arm injection site reaction. Patient states he had hepatitis A vaccination injection in his proximal left upper extremity on 10/3/18. Patient states about 3 weeks following injection he noticed redness and swelling of the proximal left upper extremity near injection site. Patient states the area was sore and swollen. States any other end of October/beginning of November the area on his proximal left upper extremity was lanced. Reports the area draining a large amount of yellow drainage at that time. States he was also put on antibiotics. Patient reports the area to the long time to heal and never completely healed. Reports S scab would appear, he would wash it off, and it would grow back. States the area on his proximal left upper extremity opened up about 1 week ago. Reports erythema. Rates pain 1/10. Denies fever, sweats, chills. I and D performed, cultures obtained, WTD dsg BID.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Increased tendency to bruise, Influenza like illness, Joint noise, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization and injection site warmth. On an unknown date, the patient experienced injection site tingling, jerkiness and increased tendency to bruise. On an unknown date, the outcome of the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth and injection site tingling were recovered/resolved and the outcome of the jerkiness and increased tendency to bruise were not recovered/not resolved.  It was unknown if the reporter considered the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth, injection site tingling, jerkiness and increased tendency to bruise to be related to SHINGRIX. Additional details were provided as follows: The patient that received the 1st dose of SHINGRIX. The evening of the vaccination the patient developed soreness in the vaccinated arm, flu symptoms, fatigue that progressed, and a swollen, sensitive, warm area the size of a tea cup. These symptoms resolved after several weeks. Three weeks after the vaccine, patient experienced a tingling in the arm that just resolved a few days ago. Patient still feels that vaccinated arm was popping with movement. Patient also noticed she was bruising easily. Patient did not seek medical help from doctor. The reporter gave consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Paraesthesia, Skin warm, Swelling, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization and injection site warmth. On an unknown date, the patient experienced injection site tingling, jerkiness and increased tendency to bruise. On an unknown date, the outcome of the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth and injection site tingling were recovered/resolved and the outcome of the jerkiness and increased tendency to bruise were not recovered/not resolved.  It was unknown if the reporter considered the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth, injection site tingling, jerkiness and increased tendency to bruise to be related to SHINGRIX. Additional details were provided as follows: The patient that received the 1st dose of SHINGRIX. The evening of the vaccination the patient developed soreness in the vaccinated arm, flu symptoms, fatigue that progressed, and a swollen, sensitive, warm area the size of a tea cup. These symptoms resolved after several weeks. Three weeks after the vaccine, patient experienced a tingling in the arm that just resolved a few days ago. Patient still feels that vaccinated arm was popping with movement. Patient also noticed she was bruising easily. Patient did not seek medical help from doctor. The reporter gave consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Fatigue, Increased tendency to bruise, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization and injection site warmth. On an unknown date, the patient experienced injection site tingling, jerkiness and increased tendency to bruise. On an unknown date, the outcome of the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth and injection site tingling were recovered/resolved and the outcome of the jerkiness and increased tendency to bruise were not recovered/not resolved.  It was unknown if the reporter considered the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth, injection site tingling, jerkiness and increased tendency to bruise to be related to SHINGRIX. Additional details were provided as follows: The patient that received the 1st dose of SHINGRIX. The evening of the vaccination the patient developed soreness in the vaccinated arm, flu symptoms, fatigue that progressed, and a swollen, sensitive, warm area the size of a tea cup. These symptoms resolved after several weeks. Three weeks after the vaccine, patient experienced a tingling in the arm that just resolved a few days ago. Patient still feels that vaccinated arm was popping with movement. Patient also noticed she was bruising easily. Patient did not seek medical help from doctor. The reporter gave consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site paraesthesia, Injection site swelling, Injection site warmth, Sensitisation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization and injection site warmth. On an unknown date, the patient experienced injection site tingling, jerkiness and increased tendency to bruise. On an unknown date, the outcome of the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth and injection site tingling were recovered/resolved and the outcome of the jerkiness and increased tendency to bruise were not recovered/not resolved.  It was unknown if the reporter considered the injection site swelling, injection site pain, influenza-like symptoms, fatigue, sensitization, injection site warmth, injection site tingling, jerkiness and increased tendency to bruise to be related to SHINGRIX. Additional details were provided as follows: The patient that received the 1st dose of SHINGRIX. The evening of the vaccination the patient developed soreness in the vaccinated arm, flu symptoms, fatigue that progressed, and a swollen, sensitive, warm area the size of a tea cup. These symptoms resolved after several weeks. Three weeks after the vaccine, patient experienced a tingling in the arm that just resolved a few days ago. Patient still feels that vaccinated arm was popping with movement. Patient also noticed she was bruising easily. Patient did not seek medical help from doctor. The reporter gave consent to follow up.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Feeling cold, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative, and refers to a 74 year old female patient. The patient's concurrent conditions included osteopenia, hyperlipidaemia, bladder muscle dysfunction, solitary nodule of the lung mass and plantar fasciitis. The patient's concomitant therapies included vitamins supplements. On 28-JAN-2019, at 09:00 AM, the patient was vaccinated with PNEUMOVAX 23 0.5ml dose, lot # R021048 with expiration date, on 14-APR-2020, injected at the deltoid muscle area for prophylaxis. On the same date, at 04:00 PM, the patient experienced chills and a slight shakiness and had to lie down. By the morning of 29-JAN-2019, the patient's arm swelled and was hot to touch so the patient put ice on it and by noon had a red mark running down the arm and across to the elbow where the swelling was. By late afternoon, the red mark had disappeared. By the morning of 30-JAN-2019, there was still some swelling but the heat was gone and the arm was almost back to normal. The outcome of the chills was unknown. The causal relationship between vaccination with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tremor
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative, and refers to a 74 year old female patient. The patient's concurrent conditions included osteopenia, hyperlipidaemia, bladder muscle dysfunction, solitary nodule of the lung mass and plantar fasciitis. The patient's concomitant therapies included vitamins supplements. On 28-JAN-2019, at 09:00 AM, the patient was vaccinated with PNEUMOVAX 23 0.5ml dose, lot # R021048 with expiration date, on 14-APR-2020, injected at the deltoid muscle area for prophylaxis. On the same date, at 04:00 PM, the patient experienced chills and a slight shakiness and had to lie down. By the morning of 29-JAN-2019, the patient's arm swelled and was hot to touch so the patient put ice on it and by noon had a red mark running down the arm and across to the elbow where the swelling was. By late afternoon, the red mark had disappeared. By the morning of 30-JAN-2019, there was still some swelling but the heat was gone and the arm was almost back to normal. The outcome of the chills was unknown. The causal relationship between vaccination with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Peripheral swelling, Skin warm, Tremor
Clinical narrative: This spontaneous report was received from a registered nurse, via company representative, and refers to a 74 year old female patient. The patient's concurrent conditions included osteopenia, hyperlipidaemia, bladder muscle dysfunction, solitary nodule of the lung mass and plantar fasciitis. The patient's concomitant therapies included vitamins supplements. On 28-JAN-2019, at 09:00 AM, the patient was vaccinated with PNEUMOVAX 23 0.5ml dose, lot # R021048 with expiration date, on 14-APR-2020, injected at the deltoid muscle area for prophylaxis. On the same date, at 04:00 PM, the patient experienced chills and a slight shakiness and had to lie down. By the morning of 29-JAN-2019, the patient's arm swelled and was hot to touch so the patient put ice on it and by noon had a red mark running down the arm and across to the elbow where the swelling was. By late afternoon, the red mark had disappeared. By the morning of 30-JAN-2019, there was still some swelling but the heat was gone and the arm was almost back to normal. The outcome of the chills was unknown. The causal relationship between vaccination with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 69-year-old male patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) and (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 28th January 2019, 6 days after receiving SHINGRIX, the patient experienced herpes zoster and rash. On an unknown date, the outcome of the herpes zoster was not recovered/not resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the herpes zoster and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in left deltoid. Six days later developed a herpes zoster lesion. Herpes zoster rash was on right trunk. On 30th January 2019, the patient was seen by the physician where he was diagnosed as herpes zoster and treatment was initiated. The reporter provided two lot numbers but was unsure which was associated with the antigen vs adjuvant.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 69-year-old male patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) and (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 28th January 2019, 6 days after receiving SHINGRIX, the patient experienced herpes zoster and rash. On an unknown date, the outcome of the herpes zoster was not recovered/not resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the herpes zoster and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in left deltoid. Six days later developed a herpes zoster lesion. Herpes zoster rash was on right trunk. On 30th January 2019, the patient was seen by the physician where he was diagnosed as herpes zoster and treatment was initiated. The reporter provided two lot numbers but was unsure which was associated with the antigen vs adjuvant.