chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Electromyogram, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: One week after receiving flu shot, my left arm from shoulder to wrist went numb and extremely painful. Approx. 6 weeks later my left hand became paralyzed.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paralysis
Clinical narrative: One week after receiving flu shot, my left arm from shoulder to wrist went numb and extremely painful. Approx. 6 weeks later my left hand became paralyzed.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia, Scar, Tremor
Clinical narrative: Shortly after midnight on same day as vaccine, started a fever, slight headache, chills and uncontrollable shaking. Fever stayed for 3 days and had several pock marks on cheek and in hairline.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: Shortly after midnight on same day as vaccine, started a fever, slight headache, chills and uncontrollable shaking. Fever stayed for 3 days and had several pock marks on cheek and in hairline.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Shortly after midnight on same day as vaccine, started a fever, slight headache, chills and uncontrollable shaking. Fever stayed for 3 days and had several pock marks on cheek and in hairline.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Painful site and swollen arm.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Headache, Incorrect dose administered, Vaccination site pain
Clinical narrative: During Health Assessment patient reported that he had received an entire vial (approximately 5.0mL) of the Anthrax vaccine while receiving his third scheduled dose. Reported localized soreness at vaccination site (L deltoid) for one and a half weeks, as well as, a headache lasting approximately 3 days post vaccination. Currently all symptoms have resolved and no reoccurrence express at this time.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Headache, Injection site pain
Clinical narrative: During Health Assessment patient reported that he had received an entire vial (approximately 5.0mL) of the Anthrax vaccine while receiving his third scheduled dose. Reported localized soreness at vaccination site (L deltoid) for one and a half weeks, as well as, a headache lasting approximately 3 days post vaccination. Currently all symptoms have resolved and no reoccurrence express at this time.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Joint stiffness, Pyrexia, Vision blurred
Clinical narrative: Fever. Severe joint pain and stiffness ankles, knees, wrists, blurry vision, headache lasted 24-36 hours. No medical treatment sought.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist, and refers to a currently 34-year-old pregnant female patient. No information regarding the patient's medical history was reported. Concurrent conditions included drug reactions/allergies on penicillin and macrolides. Concomitant therapies included TOPROL XL TABLETS 25mg, daily. On 29-JAN-2018, the patient was vaccinated with VARIVAX injection, lot# N008077, expiration date 09-MAR-2019 (exact dose, indication and route of administration were not provided). On 13-FEB-2018, the patient found out about being pregnant by performing pregnancy test. The LMP and EDD was not reported. It was reported that the patient did not have any visible rashes and no product quality compliant (PQC) and no adverse event was reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N021723 with expiration date 10-AUG-2019 or lot number N024567 with expiration date 07-SEP-2019, the reporter was not sure which lot the patient received, (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion in the range between 15°F to 46°F with a time frame of 228 hours and between 47°F to 77°F with a time frame of 14 hours, as recorded by a data logger. The vaccine did not have any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information it was determined that the case is now valid because patient identifier was received. Follow up formation was received from the nurse practitioner on 12-MAR-2018. This report refers to a 5-year-old female patient. The patient concurrent condition included autism spectrum disorder, allergy to egg, peanuts and OMNICEF. The patient was previously vaccinated with one dose of VARIVAX and M-M-R II but any vaccine was administered within 4 prior weeks. The patient did not have any illness at time of vaccination. On 13-FEB-1018, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot # N021723, expiration date 10-AUG-2019), subcutaneously for prophylaxis. Concomitant therapies included M-M-R II subcutaneously and KINRIX. It was reported that there was no reaction from the vaccine and that the vaccine was exposed to excursion of temperature range prior to being administered. No prescription drug treatment was required.
Sex: F
Vaccine: HEPA
Symptoms: Rash, Swelling face
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-MAR-2018, the patient received VAQTA (lot # and expiry date were not reported) at pharmacy for prophylaxis. Other suspect therapies included sterile diluent. On 03-MAR-2018 the patient experienced facial swelling and rash. On an unknown date, the patient reported that the rash was still present and the patient will be receiving medical attention at an unspecified urgent care facility. The outcome of swelling face and rash was reported as not recovered. Causality assessment was not provided by reporter. No PQC involved. No further AE information provided.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Malaise, Pyrexia, Vaccination site swelling
Clinical narrative: Low grade fever (99.3), chills, malaise, redness and swelling on the arm where vaccine administered for 5 days.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site swelling, Nausea
Clinical narrative: Swelling of LD, nausea, lightheadedness, and lasted x 2 days.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Pruritus
Clinical narrative: Client received flu vaccination at 9 AM in the morning on 2/9/18. She starting having itching and throat swelling at 5 PM that evening. She took 3 separate doses of BENADRYL during the night and the next morning. By noon, 2/10/18, she was not better and her throat was swelling more. She called EMS who transported her for treatment at Medical Center. The emergency room prescribed ATARAX and PEPCID. The medications help with itching and swelling, however, she is still having itching and swelling on 2/16/18 when the medications wear off.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vaccine was given on 3-13-18, two days later on 3/15/18 started with low grade fever and vomiting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Left leg swelling one day after injection.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: None, we called patient the same afternoon and 24 hours later. No adverse events. Patient reports he was feeling fine and back to normal activities.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: SOFTBALL SIZE RED SWOLLEN AREA WITH HEAT PRESENT NO ABSCESS.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Chest X-ray, Chills, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: LIGHT HEADED, SHORTNESS OF BREATH, NAUSEA AND VOMITING, COLD CHILLS. WENT TO THE ER FOR CARE.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Urine analysis, Vomiting
Clinical narrative: LIGHT HEADED, SHORTNESS OF BREATH, NAUSEA AND VOMITING, COLD CHILLS. WENT TO THE ER FOR CARE.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient noticed severe pain in right arm within 24 hours of injection. She has experienced difficulty raising her arm due to the pain for the past 4 months since the injection.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product preparation error
Clinical narrative: Patient is a nurse and decided to self-administer. She did not read the instructions and drew up and gave herself the adjuvant only. Therefore, she did not get any antigen. She had a sore arm, but this is expected from the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Patient reported flu like symptoms with fever.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Patient reported flu like symptoms with fever.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever, chills and flu like symptoms lasting 48 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Fever, chills and flu like symptoms lasting 48 hours.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Arthralgia, Blood pressure increased, Fatigue, Headache
Clinical narrative: A couple hours after receiving the vaccine my arm became more sore- more so than with any other vaccine I have ever had. At 2pm I became very tired and fell asleep for two hours. At 4pm I was unable to rest without any pain in my affected extremity. At 5:30pm I went to the grocery store and started to experience nausea and joint pain in my lower extremities. I went into the ER at 7pm because I was brought to tears with pain from my injection site when trying to change shirts. At this point I had a headache, nausea, joint pain, stomach aches, a fever (101.5), severe pain in my right arm, and a rash from my injection site across my chest and to my left upper arm.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Heart rate increased, Injection site pain, Injection site rash, Nausea, Pain in extremity
Clinical narrative: A couple hours after receiving the vaccine my arm became more sore- more so than with any other vaccine I have ever had. At 2pm I became very tired and fell asleep for two hours. At 4pm I was unable to rest without any pain in my affected extremity. At 5:30pm I went to the grocery store and started to experience nausea and joint pain in my lower extremities. I went into the ER at 7pm because I was brought to tears with pain from my injection site when trying to change shirts. At this point I had a headache, nausea, joint pain, stomach aches, a fever (101.5), severe pain in my right arm, and a rash from my injection site across my chest and to my left upper arm.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Rash
Clinical narrative: A couple hours after receiving the vaccine my arm became more sore- more so than with any other vaccine I have ever had. At 2pm I became very tired and fell asleep for two hours. At 4pm I was unable to rest without any pain in my affected extremity. At 5:30pm I went to the grocery store and started to experience nausea and joint pain in my lower extremities. I went into the ER at 7pm because I was brought to tears with pain from my injection site when trying to change shirts. At this point I had a headache, nausea, joint pain, stomach aches, a fever (101.5), severe pain in my right arm, and a rash from my injection site across my chest and to my left upper arm.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Lip pain, Pyrexia, Trigeminal neuralgia
Clinical narrative: Flu like sx with fever. Trigeminal pain on lips.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Impaired work ability, Influenza like illness, Lip blister
Clinical narrative: Flu like sx with fever. Trigeminal pain on lips.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Pyrexia, Tremor, Trigeminal neuralgia
Clinical narrative: Flu like sx with fever. Trigeminal pain on lips.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Lip pain, Pyrexia, Trigeminal neuralgia
Clinical narrative: The next day I got 102 fever and shaking chills I felt flu like symptoms that lasted for 48 hours. I had to leave work. I am a physician and found this very disturbing. I called my friend an infectious disease doctor and he said no such reaction had been reported. Then on march 2nd i developed blisters on my lip and left cheek. At first I didn't think they were at all related to the vaccine but i never had an allergic reaction before. Since my lip became swollen I took benedryl.. 3 days later I developed Trigeminal neuralgia on the same side. It lasted for 5 days and I was scheduling an MRI when all the symptoms abruptly disappeared. I do believe it was all vaccine related.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Impaired work ability, Influenza like illness, Lip blister
Clinical narrative: The next day I got 102 fever and shaking chills I felt flu like symptoms that lasted for 48 hours. I had to leave work. I am a physician and found this very disturbing. I called my friend an infectious disease doctor and he said no such reaction had been reported. Then on march 2nd i developed blisters on my lip and left cheek. At first I didn't think they were at all related to the vaccine but i never had an allergic reaction before. Since my lip became swollen I took benedryl.. 3 days later I developed Trigeminal neuralgia on the same side. It lasted for 5 days and I was scheduling an MRI when all the symptoms abruptly disappeared. I do believe it was all vaccine related.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Pyrexia, Tremor, Trigeminal neuralgia
Clinical narrative: The next day I got 102 fever and shaking chills I felt flu like symptoms that lasted for 48 hours. I had to leave work. I am a physician and found this very disturbing. I called my friend an infectious disease doctor and he said no such reaction had been reported. Then on march 2nd i developed blisters on my lip and left cheek. At first I didn't think they were at all related to the vaccine but i never had an allergic reaction before. Since my lip became swollen I took benedryl.. 3 days later I developed Trigeminal neuralgia on the same side. It lasted for 5 days and I was scheduling an MRI when all the symptoms abruptly disappeared. I do believe it was all vaccine related.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swollen, red (then later bruising) at injection site. Fever. Next day (3/9/2018) vomiting, fatigue, headache. Side effects continued for 3 days then began to lessen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Swollen, red (then later bruising) at injection site. Fever. Next day (3/9/2018) vomiting, fatigue, headache. Side effects continued for 3 days then began to lessen.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, concerning a 12-year-old female patient. No information regarding the patients' medical history or concurrent conditions was provided. The patient was a part of a retrospective analysis that studied the impact of 7-valent pneumococcal conjugate vaccine (PCV7) on the incidence of invasive pneumococcal disease (IPD) in cancer patients, along 20 years. The patients included were registered with at least 1 visit between 01-JAN-1992 and 31-DEC-2012. Unique patient-visits (UPV) (inpatient or outpatient) per calendar year, age, and cancer type were obtained from hospital databases. However, non-cancer patients were also included. Patients <15 years were considered "children", and at least 15 years old were "adults". Children 0-4 years were referred to as "vaccinees", and patients at least 5 years old were "non-vaccinees". The IPD incidences were categorized as "before PCV7" (occurred between 1992-2000), "after PCV7" (2001-2010) and "after PCV13" (2011-2012). The authors observed an abrupt decline in the incidence of IPD in 2000, coinciding with the introduction of PCV7. It remained relatively stable through 2010. The IPD incidence declined after PCV7 in children 0-4 years (vaccinees) and in at least 5 year old patients with hematologic malignancies (non-vaccinees). This suggested an indirect effect of routine childhood immunization with PCV7. They suggested that continued surveillance is warranted to characterize the burden of IPD in the era of PCV13 and optimize preventive strategies in highly immunocompromised patients. On 06-JAN-1993, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose and route of administration were not reported). There were no concomitant therapies reported. On 28-DEC-1993 ("before PCV7"), the patient was found to have invasive pneumococcal disease (type 6; one of the vaccine serogroups). The patient was hospitalized due to the event on an unknown date. No prescription drug treatment was required, however it was reported that the patient required unspecified medical/surgical intervention to prevent one of the serious outcomes. She recovered from the event on 12-JAN-1994. The authors considered the event of invasive pneumococcal disease to be medically significant, life-threatening and related to the vaccination with PNEUMOVAX 23. The physician stated that no further information was available. It was a study done via chart records from over 5 years ago, and those records were no longer available at the time of contact. This is one of several reports derived from the same literature (linked reports MARRS# 1802USA000459, 1803USA007152). Sender's Comments: US-009507513-1802USA000459.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, concerning a 55-year-old male patient. No information regarding the patient's medical history or concurrent conditions was provided. The patient was a part of a retrospective analysis that studied the impact of 7-valent pneumococcal conjugate vaccine (PCV7) on the incidence of invasive pneumococcal disease (IPD) in cancer patients, along 20 years. The patients included were registered with at least 1 visit between 01-JAN-1992 and 31-DEC-2012. Unique patient-visits (UPV) (inpatient or outpatient) per calendar year, age, and cancer type were obtained from hospital databases. However, non-cancer patients were also included. Patients <15 years were considered "children", and at least 15 years old were "adults". Children 0-4 years were referred to as "vaccinees", and patients at least 5 years old were "non-vaccinees". The IPD incidences were categorized as "before PCV7" (occurred between 1992-2000), "after PCV7" (2001-2010) and "after PCV13" (2011-2012). The authors observed an abrupt decline in the incidence of IPD in 2000, coinciding with the introduction of PCV7. It remained relatively stable through 2010. The IPD incidence declined after PCV7 in children 0-4 years (vaccinees) and in at least 5 year old patients with hematologic malignancies (non-vaccinees). This suggested an indirect effect of routine childhood immunization with PCV7. They suggested that continued surveillance is warranted to characterize the burden of IPD in the era of PCV13 and optimize preventive strategies in highly immunocompromised patients. On 26-JAN-1996, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose and route of administration were not reported). There were no concomitant therapies reported. On 01-JUN-1996 ("before PCV7"), the patient was found to have invasive pneumococcal disease (type 15; one of the vaccine serogroups). The patient was hospitalized due to the event on an unknown date (approximately in June 1996), and received unspecified prescription drug treatment. He recovered from the event on 13-JUN-1996. The authors considered the event of invasive pneumococcal disease to be medically significant (as it required medical/surgical intervention to prevent one of the serious outcomes) and related to the vaccination with PNEUMOVAX 23. The physician stated that no further information was available. It was a study done via chart records from over 5 years ago, and those records were no longer available at the time of contact. This is one of several reports derived from the same literature (linked reports MARRS# 1802USA000459, 1803USA007151). Sender's Comments: US-009507513-1802USA000459.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Incorrect dose administered, Injection site pain
Clinical narrative: Received a spontaneous report on 23JAN2018, 24JAN2018 and 25JAN2018 from a Regulatory Authority. The physician reported that on 23JAN2018, a patient who was overseas, received 5 ml of BIOTHRAX vaccine injected into the deltoid rather than the prescribed 0.5 ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medics and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Vaccines given 2/15/18 on 2/25/18 mom notices a red area with raised bumps on the Left thigh where the MMRV was given 10 days earlier. Child at clinic.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Headache, diarrhea, nausea, extreme tiredness.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, VARCEL
Symptoms: Erythema, Induration, Nodule, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Patient redness, swelling, and pain in his right arm since receiving the vaccine on 01/18/2018. 1-19-18-1/21/18 fever with max temp of 103. Describes arm felt hot and painful especially with movement. To ER 1-22/18, physician states warmth, swelling, and hard knot were due to the vaccine administered on 1-18-18. 2/13/2017 Father reports patient has pain when he has to move his arm he states "it pops and feels like the muscle is tearing of the bone".
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, VARCEL
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient redness, swelling, and pain in his right arm since receiving the vaccine on 01/18/2018. 1-19-18-1/21/18 fever with max temp of 103. Describes arm felt hot and painful especially with movement. To ER 1-22/18, physician states warmth, swelling, and hard knot were due to the vaccine administered on 1-18-18. 2/13/2017 Father reports patient has pain when he has to move his arm he states "it pops and feels like the muscle is tearing of the bone".
Age: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Cardiac function test, Cardiac monitoring, Decreased appetite, Dyspnoea
Clinical narrative: On Sunday, December 3th, I have suffered difficulty breathing, strong weakness, fever, loss of sleep, loss of appetite. I was taking to "health" facility morning of Monday 4th. After checks and tests I was released. These signs of a sever body reaction continued. I was taking to the Emergency room (ER) on 12/06/2017 for the same symptoms stated above. At the ER, I went through all required tests and then I was released after few hours. I suffered from the difficulty breathing for weeks. I have visited my primary doctor care where I done more tests and I wear a device to monitor my heart for few days. I traveled outside of the country Jan 07/2018 and on Jan 29/2018 I suffered again most of symptoms stated above. I visited a doctor office where I done cardiac test and I was given antibiotics and vitamins and 1 weeks to rest. When I returned home on the 02/07/2018 I do feel occasionally short breathing and weakness. I have lost lot of work days due to this issue. In addition to large amount of medical bills. I have all doctors visits documented.
Age: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Impaired work ability, Insomnia, Laboratory test, Pyrexia
Clinical narrative: On Sunday, December 3th, I have suffered difficulty breathing, strong weakness, fever, loss of sleep, loss of appetite. I was taking to "health" facility morning of Monday 4th. After checks and tests I was released. These signs of a sever body reaction continued. I was taking to the Emergency room (ER) on 12/06/2017 for the same symptoms stated above. At the ER, I went through all required tests and then I was released after few hours. I suffered from the difficulty breathing for weeks. I have visited my primary doctor care where I done more tests and I wear a device to monitor my heart for few days. I traveled outside of the country Jan 07/2018 and on Jan 29/2018 I suffered again most of symptoms stated above. I visited a doctor office where I done cardiac test and I was given antibiotics and vitamins and 1 weeks to rest. When I returned home on the 02/07/2018 I do feel occasionally short breathing and weakness. I have lost lot of work days due to this issue. In addition to large amount of medical bills. I have all doctors visits documented.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Fall, Fatigue, Feeling hot, Syncope
Clinical narrative: Pt was given SHINGRIX on 3/15/18 and later that night, pt c/o feeling very hot, clammy and eventually fainted in her bathroom (fell slowly- no resulting injury). Pt called pharmacy to report incident-- sx's resolved, but today 3/16/18 feeling very fatigued. Writer explained to pt that this is a normal reaction and that her body is responding to the vaccine, and encouraged pt to come back for her second dose- ADE should resolve in about 48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Nausea
Clinical narrative: Pain, stiffness at injection site, 100.8 degree F temperature, nausea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Pain, redness, soreness at site lasted about 5-6 days, redness was about 4? by 5? Fever up to 100.7. Lasted about 2-3 days. Chills about 4-5 days. Headache about 4 days. Muscle aches about 4 days.  Stomach pain evening after the injection. Nausea, diarrhea about 2 1/2 days after the injection lasted less than one day. Fatigue, continues after two weeks but not as severe.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Pain, redness, soreness at site lasted about 5-6 days, redness was about 4? by 5? Fever up to 100.7. Lasted about 2-3 days. Chills about 4-5 days. Headache about 4 days. Muscle aches about 4 days.  Stomach pain evening after the injection. Nausea, diarrhea about 2 1/2 days after the injection lasted less than one day. Fatigue, continues after two weeks but not as severe.
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray normal
Clinical narrative: Pain and immobility in left arm. Pain is worst in left shoulder.
Age: 26.0
Sex: M
Vaccine: HPV9, MNQ, PPV
Symptoms: Cellulitis
Clinical narrative: Right arm cellulitis.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, erythema, warmth.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Dyskinesia, Irritability, Lethargy, Oropharyngeal pain
Clinical narrative: Fever of 103, lethargy, severe fussiness, jerking and flailing in sleep (possible febrile seizure), not sleeping well and waking up screaming. Swollen legs, cough, runny nose, sore throat, possibly ear infection. Treating with antibiotics.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Peripheral swelling, Poor quality sleep, Pyrexia, Rhinorrhoea, Screaming
Clinical narrative: Fever of 103, lethargy, severe fussiness, jerking and flailing in sleep (possible febrile seizure), not sleeping well and waking up screaming. Swollen legs, cough, runny nose, sore throat, possibly ear infection. Treating with antibiotics.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed a rash about 1.5 inches wide by 3 inches long at injection site. Area was slightly raised, red, and warm to the touch.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Hypersomnia, Lethargy
Clinical narrative: Patient became seriously lethargic and wouldn't even smile. She slept nearly 2 days straight except to eat. Did not call doctor because we were told she may be very sleepy and even run a fever but not to worry. No fever. Her lethargic state scared us terribly but we trusted she was ok even though her older sister never had a reaction like that! She would take her bottles. We didn't even see her precious smile again until day 2 and it was several hours after that before she did it again. We were so glad to see that smile but the baby we knew was absent those 2 days. Something wasn't right.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash erythematous, Rash pustular, Viral test
Clinical narrative: PATIENT RECEIVED SMALLPOX VACCINE 03/01/2018 AND ON 03/08/2018 PT STATES THAT HE STARTED TO SEE SMALL RED BUMPS ALONG HIS HAIRLINE. PT PRESENTED TO CLINIC 03/15/2018 AND STATES THAT HE HAS RED BUMPS ON HIS CHEST AND BACK. TWO BUMPS ON THE BACK HAS FORMED PUSTULES. PT HAS BEEN PLACED ON BED REST FOR 72 HRS AND INSTRUCTED TO RETURN TO THE CLINIC IF RASH GETS WORSE.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: DTaP was ordered but PEDIARIX was given. Health department notified.
Sex: U
Vaccine: PPV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 28-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot # N023650 and expiration date: 20-MAY-2019) intramuscularly from a pre-filled syringe which broke right after the administration. It was unknown whether the prefilled syringe had any defects prior to the administration. It was reported that the luer lock broke off at the tip of the glass of syringe. No known adverse effects reported. Product quality complaint was filed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient developed extreme arm pain, heat, swelling in arm that radiated to fingers - developed cellulitis that required antibiotic given on 03/07/18.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Allergy test, Asthma, Blood test, Dyspnoea
Clinical narrative: Considering that baby was born as a perfectly normal and healthy baby, who was eating, sleeping, and gaining weight great, right after the vaccination baby had fever, followed by inflamed with bright red color cheeks, started to have congested nose and developed wheezing. Breathing became an issue and inflammation in the skin of the face started to bleed badly. Baby became very restless, nights became a nightmare as he could not breathe, and was itching like crazy. He stopped being himself and was in constant pain. We had to visit emergency, because he could not breathe. Visited numerous specialty doctors, who said the baby has severe eczema, asthma, allergies, etc. he also stopped gaining weight, had low hemoglobin.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Eczema, Erythema, Haemoglobin decreased, Hypersensitivity, Inflammation
Clinical narrative: Considering that baby was born as a perfectly normal and healthy baby, who was eating, sleeping, and gaining weight great, right after the vaccination baby had fever, followed by inflamed with bright red color cheeks, started to have congested nose and developed wheezing. Breathing became an issue and inflammation in the skin of the face started to bleed badly. Baby became very restless, nights became a nightmare as he could not breathe, and was itching like crazy. He stopped being himself and was in constant pain. We had to visit emergency, because he could not breathe. Visited numerous specialty doctors, who said the baby has severe eczema, asthma, allergies, etc. he also stopped gaining weight, had low hemoglobin.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Nasal congestion, Pain, Pruritus, Pyrexia, Restlessness
Clinical narrative: Considering that baby was born as a perfectly normal and healthy baby, who was eating, sleeping, and gaining weight great, right after the vaccination baby had fever, followed by inflamed with bright red color cheeks, started to have congested nose and developed wheezing. Breathing became an issue and inflammation in the skin of the face started to bleed badly. Baby became very restless, nights became a nightmare as he could not breathe, and was itching like crazy. He stopped being himself and was in constant pain. We had to visit emergency, because he could not breathe. Visited numerous specialty doctors, who said the baby has severe eczema, asthma, allergies, etc. he also stopped gaining weight, had low hemoglobin.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Skin haemorrhage, Weight gain poor, Wheezing
Clinical narrative: Considering that baby was born as a perfectly normal and healthy baby, who was eating, sleeping, and gaining weight great, right after the vaccination baby had fever, followed by inflamed with bright red color cheeks, started to have congested nose and developed wheezing. Breathing became an issue and inflammation in the skin of the face started to bleed badly. Baby became very restless, nights became a nightmare as he could not breathe, and was itching like crazy. He stopped being himself and was in constant pain. We had to visit emergency, because he could not breathe. Visited numerous specialty doctors, who said the baby has severe eczema, asthma, allergies, etc. he also stopped gaining weight, had low hemoglobin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles. Eye on right side, eyelid, right forehead, up into hair on right side into crown of head on right side.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: March 14 2:00 PM experiencing flu like symptoms and fatigue, took two BAYER Aspirin x 325mg. Normal appetite at dinner. By 7:30 PM to bed due to extreme chills that dissipated once in bed. Worked 5 hour day on March 15 took two aspirin. Injection site and large area very red and warm to touch. As of today, March 16 site is still red, warm and swollen.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: March 14 2:00 PM experiencing flu like symptoms and fatigue, took two BAYER Aspirin x 325mg. Normal appetite at dinner. By 7:30 PM to bed due to extreme chills that dissipated once in bed. Worked 5 hour day on March 15 took two aspirin. Injection site and large area very red and warm to touch. As of today, March 16 site is still red, warm and swollen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: This morning, the day after the vaccine: chills, nausea, fever of 100.5. Still ongoing ? it's been less than 24 hours since the injection.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: PATIENT GIVEN EXPIRED VACCINE EXP: 3/12/18 GIVEN 3/13/18.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO REACTION PATIENT GIVEN EXPIRED VACCINE. EXP: 3/12/18 GIVEN 3/13/18.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Abnormal faeces, Asthenia, Crying, Dyskinesia, Electroencephalogram normal
Clinical narrative: He had a fever the night of the vaccination. His arms and legs were jerking involuntarily while he slept, often rotating one arm to the next, to the leg and so on. Prior to these vaccinations he was able to sit very well, and also would push himself up on his legs very easily while we were balancing him, and did it at every opportunity. After the vaccinations, he was unable to sit by himself without falling over, and refused to push himself up most of the time. When he did push up, his legs would buckle under him very quickly. He was crying with a very unusual high pitched cry. We took him to the emergency room in the middle of the night due to his high fever, where they assessed him as "normal" since his temperature went down. We were told that fevers could be caused by vaccines, but the limb flinching and muscle weakness were mostly ignored. Over the next few days we continued to monitor him, and his muscle weakness did not improve. He went from pushing himself up on his legs very easily and strongly pre-vaccination, to barely being able to hold himself up for a second, and his legs like jelly, giving way easily. The day after vaccinations, he started having long periods of staring, and not responding to anything we said or did to get his attention. We took him to the pediatrician, and on the way, we caught a video of him in one of his staring episodes, not responding to us at all. The doctor saw this video, and was concerned, so sent us to a neurologist the same day. The neurologist examined him, but he did not have any staring episodes during the examination. She considered him to be "normal", because she was not aware of his previous strength, and how much he had weakened post-vaccination. We were sent to pediatric neurology at the main Clinic campus to stay overnight, and have an EEG overnight. The doctors also considered him "normal", because they were unaware of his normal temperament and physical strength. They thought his post-vaccination weakness and temperament were simply "normal for his age". We were sent home, and he continued to be abnormal for about 2 weeks. Over the next couple of weeks: - he would wake up in the night screaming constantly - he continued to be very weak in his legs, refusing to push himself up where he used to do it constantly - his eyes would roll back in his head randomly, and often look very dazed - he continued to have abnormal twitching in his sleep, different from normal sleep movements - His urine and poop smelled like chemicals for 8 days - His poop was frothy and green for 14 days.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Eye movement disorder, Faeces discoloured, Feeling abnormal, Middle insomnia, Muscle twitching
Clinical narrative: He had a fever the night of the vaccination. His arms and legs were jerking involuntarily while he slept, often rotating one arm to the next, to the leg and so on. Prior to these vaccinations he was able to sit very well, and also would push himself up on his legs very easily while we were balancing him, and did it at every opportunity. After the vaccinations, he was unable to sit by himself without falling over, and refused to push himself up most of the time. When he did push up, his legs would buckle under him very quickly. He was crying with a very unusual high pitched cry. We took him to the emergency room in the middle of the night due to his high fever, where they assessed him as "normal" since his temperature went down. We were told that fevers could be caused by vaccines, but the limb flinching and muscle weakness were mostly ignored. Over the next few days we continued to monitor him, and his muscle weakness did not improve. He went from pushing himself up on his legs very easily and strongly pre-vaccination, to barely being able to hold himself up for a second, and his legs like jelly, giving way easily. The day after vaccinations, he started having long periods of staring, and not responding to anything we said or did to get his attention. We took him to the pediatrician, and on the way, we caught a video of him in one of his staring episodes, not responding to us at all. The doctor saw this video, and was concerned, so sent us to a neurologist the same day. The neurologist examined him, but he did not have any staring episodes during the examination. She considered him to be "normal", because she was not aware of his previous strength, and how much he had weakened post-vaccination. We were sent to pediatric neurology at the main Clinic campus to stay overnight, and have an EEG overnight. The doctors also considered him "normal", because they were unaware of his normal temperament and physical strength. They thought his post-vaccination weakness and temperament were simply "normal for his age". We were sent home, and he continued to be abnormal for about 2 weeks. Over the next couple of weeks: - he would wake up in the night screaming constantly - he continued to be very weak in his legs, refusing to push himself up where he used to do it constantly - his eyes would roll back in his head randomly, and often look very dazed - he continued to have abnormal twitching in his sleep, different from normal sleep movements - His urine and poop smelled like chemicals for 8 days - His poop was frothy and green for 14 days.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Muscular weakness, Posture abnormal, Pyrexia, Screaming, Staring
Clinical narrative: He had a fever the night of the vaccination. His arms and legs were jerking involuntarily while he slept, often rotating one arm to the next, to the leg and so on. Prior to these vaccinations he was able to sit very well, and also would push himself up on his legs very easily while we were balancing him, and did it at every opportunity. After the vaccinations, he was unable to sit by himself without falling over, and refused to push himself up most of the time. When he did push up, his legs would buckle under him very quickly. He was crying with a very unusual high pitched cry. We took him to the emergency room in the middle of the night due to his high fever, where they assessed him as "normal" since his temperature went down. We were told that fevers could be caused by vaccines, but the limb flinching and muscle weakness were mostly ignored. Over the next few days we continued to monitor him, and his muscle weakness did not improve. He went from pushing himself up on his legs very easily and strongly pre-vaccination, to barely being able to hold himself up for a second, and his legs like jelly, giving way easily. The day after vaccinations, he started having long periods of staring, and not responding to anything we said or did to get his attention. We took him to the pediatrician, and on the way, we caught a video of him in one of his staring episodes, not responding to us at all. The doctor saw this video, and was concerned, so sent us to a neurologist the same day. The neurologist examined him, but he did not have any staring episodes during the examination. She considered him to be "normal", because she was not aware of his previous strength, and how much he had weakened post-vaccination. We were sent to pediatric neurology at the main Clinic campus to stay overnight, and have an EEG overnight. The doctors also considered him "normal", because they were unaware of his normal temperament and physical strength. They thought his post-vaccination weakness and temperament were simply "normal for his age". We were sent home, and he continued to be abnormal for about 2 weeks. Over the next couple of weeks: - he would wake up in the night screaming constantly - he continued to be very weak in his legs, refusing to push himself up where he used to do it constantly - his eyes would roll back in his head randomly, and often look very dazed - he continued to have abnormal twitching in his sleep, different from normal sleep movements - His urine and poop smelled like chemicals for 8 days - His poop was frothy and green for 14 days.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Unresponsive to stimuli, Urine odour abnormal
Clinical narrative: He had a fever the night of the vaccination. His arms and legs were jerking involuntarily while he slept, often rotating one arm to the next, to the leg and so on. Prior to these vaccinations he was able to sit very well, and also would push himself up on his legs very easily while we were balancing him, and did it at every opportunity. After the vaccinations, he was unable to sit by himself without falling over, and refused to push himself up most of the time. When he did push up, his legs would buckle under him very quickly. He was crying with a very unusual high pitched cry. We took him to the emergency room in the middle of the night due to his high fever, where they assessed him as "normal" since his temperature went down. We were told that fevers could be caused by vaccines, but the limb flinching and muscle weakness were mostly ignored. Over the next few days we continued to monitor him, and his muscle weakness did not improve. He went from pushing himself up on his legs very easily and strongly pre-vaccination, to barely being able to hold himself up for a second, and his legs like jelly, giving way easily. The day after vaccinations, he started having long periods of staring, and not responding to anything we said or did to get his attention. We took him to the pediatrician, and on the way, we caught a video of him in one of his staring episodes, not responding to us at all. The doctor saw this video, and was concerned, so sent us to a neurologist the same day. The neurologist examined him, but he did not have any staring episodes during the examination. She considered him to be "normal", because she was not aware of his previous strength, and how much he had weakened post-vaccination. We were sent to pediatric neurology at the main Clinic campus to stay overnight, and have an EEG overnight. The doctors also considered him "normal", because they were unaware of his normal temperament and physical strength. They thought his post-vaccination weakness and temperament were simply "normal for his age". We were sent home, and he continued to be abnormal for about 2 weeks. Over the next couple of weeks: - he would wake up in the night screaming constantly - he continued to be very weak in his legs, refusing to push himself up where he used to do it constantly - his eyes would roll back in his head randomly, and often look very dazed - he continued to have abnormal twitching in his sleep, different from normal sleep movements - His urine and poop smelled like chemicals for 8 days - His poop was frothy and green for 14 days.