chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RVX
Symptoms: Death, Pneumonia, Respiratory failure
Clinical narrative: This case was reported in a literature article and described the occurrence of respiratory failure in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included HIV infection. On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included pneumonia with serious criteria of GSK medically significant. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included pneumonia (unknown). The reported cause of death was respiratory failure. The investigator considered that there was a reasonable possibility that the respiratory failure and pneumonia may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia and respiratory failure in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had human immunodeficiency virus (HIV) infection. No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was respiratory failure. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB". This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Reported Cause(s) of Death: Respiratory failure.
Sex: U
Vaccine: RVX
Symptoms: Failure to thrive
Clinical narrative: This case was reported in a literature article and described the occurrence of failure to thrive in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed failure to thrive. Serious criteria included GSK medically significant. The outcome of failure to thrive was unknown. The investigator considered that there was a reasonable possibility that the failure to thrive may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence failure to thrive of in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed failure to thrive. The treatment was unknown. The outcome of the event was not provided. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Fatigue, Impaired work ability, Musculoskeletal stiffness
Clinical narrative: During day after shot, some stiffness in arm (nothing unexpected). Leaving work about 5:30 pm, felt general muscle stiffness in neck/shoulder area, that was indicative to me of starting to feel an illness coming on. I then realized it was probably an effect of vaccine. Ate dinner and was starting to feel better. Went for walk and still had some right shoulder/upper arm stiffness, but otherwise felt good. Got home around 9pm and started to read. Stayed in about same position in chair for about an hour, and started feeling tired. I stood up and felt muscle and joint pain throughout my body. Felt feverish. Took Advil (2) but was feeling very uncomfortable, shaky, and joint and muscle pain all over. Went to bed and had difficulty getting comfortable. Slept on and off until about 4 am. Felt like muscle and joint pain were easing but by no means gone. Woke up a little after 7 am and emailed work saying I would try to be in by 11. Felt like fever had broke, but still had some lingering muscle and joint pain, but not as bad as earlier. Slept for two hours until 9:30 am. Woke up but still didn?t feel well enough to go into work. Most muscle and joint pain has resolved, but still feeling tired (possibly from poor sleep over night). Checked Unknown as to recovery as I still feel some negative impact and am hopeful that the bad feelings won?t return.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: During day after shot, some stiffness in arm (nothing unexpected). Leaving work about 5:30 pm, felt general muscle stiffness in neck/shoulder area, that was indicative to me of starting to feel an illness coming on. I then realized it was probably an effect of vaccine. Ate dinner and was starting to feel better. Went for walk and still had some right shoulder/upper arm stiffness, but otherwise felt good. Got home around 9pm and started to read. Stayed in about same position in chair for about an hour, and started feeling tired. I stood up and felt muscle and joint pain throughout my body. Felt feverish. Took Advil (2) but was feeling very uncomfortable, shaky, and joint and muscle pain all over. Went to bed and had difficulty getting comfortable. Slept on and off until about 4 am. Felt like muscle and joint pain were easing but by no means gone. Woke up a little after 7 am and emailed work saying I would try to be in by 11. Felt like fever had broke, but still had some lingering muscle and joint pain, but not as bad as earlier. Slept for two hours until 9:30 am. Woke up but still didn?t feel well enough to go into work. Most muscle and joint pain has resolved, but still feeling tired (possibly from poor sleep over night). Checked Unknown as to recovery as I still feel some negative impact and am hopeful that the bad feelings won?t return.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Oedema, Oedema peripheral, Rash, Rash pruritic
Clinical narrative: Individual reported to me verbally that she experienced an itchy rash that started on her chest and pitting edema on her left foot/ankle. Edema started the night of the vaccine administration and the rash started the next day, June 1, 2019. She followed up with her primary care provider.
Age: 2.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: swollen r thigh with fever >101.  thigh also red and tender to touch.  difficulty walking on leg.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Basal ganglia stroke, Fall, Fatigue, Hemiparesis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: PT FELT FATIGUED AND WEAK ON RIGHT SIDE ON 5/21. ON 5/22 AT 3AM FELL GOING TO BATHROOM AND COULD NOT GET UP. WENT TO ER AND MRI SHOWED MILD STROKE IN THE BASAL GANGLIA
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pain in extremity
Clinical narrative: Chills, chattering teeth, weakness, headache, sore arm
Age: 25.0
Sex: F
Vaccine: HPV9, TD
Symptoms: Discomfort, Paraesthesia
Clinical narrative: Patient reports tingling to borth arma from elbow down, feeling pressure in fingers.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Patient felt chills the evening she received the vaccine on 5/28/19.  On Thursday 5/30/19 she had a fever of 99.9 degrees F. On Friday she felt nauseous and vomiting and then fainted. She also had spots that she described as a measles like rash on her leg.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Vomiting
Clinical narrative: Patient felt chills the evening she received the vaccine on 5/28/19.  On Thursday 5/30/19 she had a fever of 99.9 degrees F. On Friday she felt nauseous and vomiting and then fainted. She also had spots that she described as a measles like rash on her leg.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Nervousness, Product administered at inappropriate site
Clinical narrative: patient received 4 vaccines. after the last vaccine (HPV) patient lost consciousness approximately 3 seconds. patient was nervous and did not eat or drink prior to office visit.  she requested to have vaccines administered in legs instead of arms. patient was monitored by Dr, nurse and parent for at least 30 minutes after episode. was given water and snack. BP 95/68 pulse 90
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient did not experience any adverse reactions to the extra immunization. I gave the Proquad that contains both the MMR and Varicella. Then also to that, I gave a Varicella.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt received 3 injection and was asked to stay for 10 to 15 mins afterwards per protocol . Within 3 mins of injections pt become faint and slide over on the table . She regained consciousness after approx. 1 minute. Vitals were checked and where WNL. Dr was notified. Pt was able to ambulate on her own within 15 mins. and was fully alert. She was discharged at that time
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none - no adverse effects. Just reporting the error.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Urticaria
Clinical narrative: Muscle aches, chills, shivering, sweating, fatigue within 12 -24 hours.  Hives on left arm 48 hours after vaccine was given.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Mother called to say patient's thighs were red and swollen. He was also vomiting anything he drank. Recommended that she put cool compresses on his thighs and take him to the health clinic on 14.7 to be seen by a physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Electrocardiogram, Head injury
Clinical narrative: At midnight I passed out while on the toilet.  Hitting my head on tile floor.  Laid on back until husband arrived.  Passed out 2 more times on the toilet and then called 911.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: At midnight I passed out while on the toilet.  Hitting my head on tile floor.  Laid on back until husband arrived.  Passed out 2 more times on the toilet and then called 911.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 68 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 23-AUG-2016, the pt was vaccinated at a pharmacy/drug store with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed shingles and as a result was treated by a physician. The outcome of shingles was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blindness unilateral, Emotional distress, Herpes zoster, Impaired work ability
Clinical narrative: This initial spontaneous report has been received on 30-MAY-2019 from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On 22-DEC-2015, the pt was inoculated with ZOSTAVAX (lot number, expiration date, dose and route of administration unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On or about February 2016, the pt suffered debilitating injuries including severe outbreak of shingles, optic papilledema, vision problems, swelling of optic nerve and loss of vision in left eye. The pt symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition and has suffered economic losses due to his inability to work. As a result of ZOSTAVAX, the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of ZOSTAVAX, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the events of loss of vision in left eye and optic papilledema/swelling of optic nerve were determined to be medically significant. Severe outbreak of shingles, optic papilledema, vision problems, swelling of optic nerve and loss of vision in left eye were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Papilloedema, Visual impairment
Clinical narrative: This initial spontaneous report has been received on 30-MAY-2019 from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On 22-DEC-2015, the pt was inoculated with ZOSTAVAX (lot number, expiration date, dose and route of administration unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On or about February 2016, the pt suffered debilitating injuries including severe outbreak of shingles, optic papilledema, vision problems, swelling of optic nerve and loss of vision in left eye. The pt symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition and has suffered economic losses due to his inability to work. As a result of ZOSTAVAX, the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of ZOSTAVAX, the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the events of loss of vision in left eye and optic papilledema/swelling of optic nerve were determined to be medically significant. Severe outbreak of shingles, optic papilledema, vision problems, swelling of optic nerve and loss of vision in left eye were considered to be disabling. Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse affects reported; a dose of PROQUAD was administer to a 31 year old patient; Information has been received from a medical assistant referring to a 31 years old patient of unknown gender. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.    On 30-MAY-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) (lot # R003294, expiration date 31-JUL-2019; strength, dose detail, route were not provided) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised (immune system was slightly compromised).   On 21st May 2019, the patient received the 2nd dose of Shingrix. On 23rd May 2019, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's oncologist wanted the patient to receive Shingrix to prevent the patient from shingles. The patient experienced shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Immunoglobulin therapy, Pain, Wheelchair user
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of strength loss of in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high and diabetes (controlled). In January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced strength loss of (serious criteria hospitalization and disability) and acute pain (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Intravenous Immunoglobulin). On an unknown date, the outcome of the strength loss of and acute pain were unknown. The reporter considered the strength loss of and acute pain to be related to SHINGRIX. Rerun: Additional details were provided as follows: The age at vaccination was not reported but it could be 78 or 79 years. The patient began to experience loss of strength in the legs and extreme pain.  Prior to this. Other than controlled diabetes and high blood pressure, the patient was in good health and completely self-sufficient. The patient was admitted to hospital from 20th March 2019 to 25th March 2019 and underwent numerous examinations. She also received intravenous Ig, but the treatment did not help. The patient was wheelchair bound and has begun to experience loss of strength in right arm as well. The reporting physician as well as neurology specialists believe this to be vaccine-related. The reporter wanted to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Injection site pain
Clinical narrative: Sore at injection site, fever, chills, headache, rapid heartbeat, nauseated. Most symptoms started near bedtime (10-10:30pm) lasted through the night. Following morning had headache and very tired.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Sore at injection site, fever, chills, headache, rapid heartbeat, nauseated. Most symptoms started near bedtime (10-10:30pm) lasted through the night. Following morning had headache and very tired.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ear discomfort, Lip swelling, Oral discomfort, Pyrexia, Upper respiratory tract infection
Clinical narrative: 12 month old previously healthy presents with lip swelling. Received 12 mo immunization this am around 10.30. Took once dose of PO Tylenol right after. Went home right after, no other suspected environmental exposure, no different foods or anything topical. Around 1630 developed lip - upper and lower swelling, tugs at his  lips - maybe itchy. No generalized rash or itching. Tugging a little at his ears. No noisy breathing or wheezing. Tolerating PO, no vomiting. Has been having a mild URI symptoms with low grade fever, T-99 for the past week. No known allergies - Not allergic to egg, or any kinds of food. No fam hx of angioedema like illness. This has never happened in the past or related to any immunization or Tylenol.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; the patient received the first dose of GARDASIL 9 a year ago on an unspecified date/ the patient received the second dose of GARDASIL 9 on 5/23/2019; This spontaneous report as received from a nurse refers to a 22-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In approximately May 2018 (reported as a year ago), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-MAY-2019, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602281 has been verified to be a valid lot number, expiration date reported as 02-JUL-2021, but upon internal validation established as 21-JUL-2021 (strength, dose and route of administration were not reported) for prophylaxis.  On 23-MAY-2019, the patient experienced inappropriate schedule of product administration. There was no adverse effect reported.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Exposure via eye contact, Exposure via skin contact, Eye irrigation, Eye irritation, Occupational exposure to product
Clinical narrative: Her eyes still have some burning; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; This spontaneous report was received from an office manager and refers to a 56-year-old female physician. Her concurrent condition included seasonal allergy. Her pertinent medical history and concomitant medications were not reported. She was contact lens user.  On 23-MAY-2019, the physician was administering varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034396, expiration date not reported, but upon internal validation established as 27-NOV-2020) (strength, dose, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE DILUENT MRK) (lot # N035975, expiration date not reported, but upon internal validation established as 29-AUG-2020).  On the same date, after the vaccine was reconstituted and drawn into the syringe, the syringe came apart at the needle and product got on the physician's face, including her eyes. The syringe did not come apart at any time during reconstitution or when drawing the vaccine into the syringe. The physician removed her contact lenses and rinsed her eyes with water, however her eyes still have some burning. An unspecified treatment was given for the event. No lab diagnostics were performed. At the time of reporting, the outcome of the event was reported as not recovered.  The relatedness between the event and suspected products was not provided.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Syringe issue
Clinical narrative: Her eyes still have some burning; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; This spontaneous report was received from an office manager and refers to a 56-year-old female physician. Her concurrent condition included seasonal allergy. Her pertinent medical history and concomitant medications were not reported. She was contact lens user.  On 23-MAY-2019, the physician was administering varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034396, expiration date not reported, but upon internal validation established as 27-NOV-2020) (strength, dose, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE DILUENT MRK) (lot # N035975, expiration date not reported, but upon internal validation established as 29-AUG-2020).  On the same date, after the vaccine was reconstituted and drawn into the syringe, the syringe came apart at the needle and product got on the physician's face, including her eyes. The syringe did not come apart at any time during reconstitution or when drawing the vaccine into the syringe. The physician removed her contact lenses and rinsed her eyes with water, however her eyes still have some burning. An unspecified treatment was given for the event. No lab diagnostics were performed. At the time of reporting, the outcome of the event was reported as not recovered.  The relatedness between the event and suspected products was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient received one dose of GARDASIL 9 about one year ago and did not complete any further dose administration.; No adverse events were reported.; This spontaneous report was received from a physician referring to an 18 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On an unknown date (reported as "about one year ago"), the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) for prophylaxis. The patient did not complete any further dose administration. No adverse events were reported.  .
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shinglesincluding any and all of its sequelae; Information has been received on 30-MAY-2019 from a lawyer regarding a case in litigation, concerning a 64-year-old male patient (pt). There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On 17-JAN-2015, the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration date, dose and route of administration unknown) for prophylaxis. On 29-MAY-2016, the pt was caused to suffer Shingles, including any and all of its sequelae. The pt was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the pt suffered Shingles and other related health complications. In addition, the pt requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses, also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring, and treatment. The pt has incurred and will continue to incur mental and physical pain and suffering. The outcome of the event is not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Eye pain, Facial pain, Fatigue
Clinical narrative: facial pain; nausea; Aching; Shivering; Fatigue; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; This case was reported by a other health professional via call center representative and described the occurrence of facial pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2019 13:00, the patient received the 1st dose of Shingrix. On 5th February 2019, 6 hrs after receiving Shingrix, the patient experienced fatigue, ear pain, headache, eye pain and oral pain. On 5th February 2019 19:00, the patient experienced nausea, pain and shivering. On 5th February 2019 23:00, the patient experienced facial pain. On 6th February 2019, the outcome of the fatigue, ear pain, headache, eye pain and oral pain were recovered/resolved. On 6th February 2019 02:00, the outcome of the facial pain, nausea, pain and shivering were recovered/resolved.   It was unknown if the reporter considered the facial pain, nausea, pain, shivering, fatigue, ear pain, headache, eye pain and oral pain to be related to Shingrix.  Additional details were provided as follows: 10 hours after vaccination, the patient experienced facial pan. 6 hours after vaccintaion, the patient experience nausea, pain and shivering. The facial pain was sharp shooting intermittent but ongoing until 2 am the following day. It was began around ear and shot into her forehead,nose,mouth, eye, and chin. The patient stated that, the facial pain was intense may be 7 out of 10 enough, that she considered going to the emergency room. Spontaneously around 2 am, the facial pain was gone and there were no ill effects afterwards than the fatigue. The fatigue was recovered after next day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Oral pain, Pain
Clinical narrative: facial pain; nausea; Aching; Shivering; Fatigue; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; It began around my ear and shot into my forehead, nose, mouth, eye, and chin; This case was reported by a other health professional via call center representative and described the occurrence of facial pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2019 13:00, the patient received the 1st dose of Shingrix. On 5th February 2019, 6 hrs after receiving Shingrix, the patient experienced fatigue, ear pain, headache, eye pain and oral pain. On 5th February 2019 19:00, the patient experienced nausea, pain and shivering. On 5th February 2019 23:00, the patient experienced facial pain. On 6th February 2019, the outcome of the fatigue, ear pain, headache, eye pain and oral pain were recovered/resolved. On 6th February 2019 02:00, the outcome of the facial pain, nausea, pain and shivering were recovered/resolved.   It was unknown if the reporter considered the facial pain, nausea, pain, shivering, fatigue, ear pain, headache, eye pain and oral pain to be related to Shingrix.  Additional details were provided as follows: 10 hours after vaccination, the patient experienced facial pan. 6 hours after vaccintaion, the patient experience nausea, pain and shivering. The facial pain was sharp shooting intermittent but ongoing until 2 am the following day. It was began around ear and shot into her forehead,nose,mouth, eye, and chin. The patient stated that, the facial pain was intense may be 7 out of 10 enough, that she considered going to the emergency room. Spontaneously around 2 am, the facial pain was gone and there were no ill effects afterwards than the fatigue. The fatigue was recovered after next day.
Sex: F
Vaccine: HPV2
Symptoms: Malaise
Clinical narrative: very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received HPV 16-18 (Cervarix) for prophylaxis.   Concurrent medical conditions included postural orthostatic tachycardia syndrome.   On an unknown date, the patient received the 2nd dose of Cervarix. On an unknown date, unknown after receiving Cervarix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Cervarix.  Additional details were reported as follows: The patient had POTS postural orthostatic tachycardia syndrome and many other issues.  It had been 3 years of suffering. The age at vaccination was not reported. The reporter's daughter was injured by HPV vaccine as well.  The patient got very sick after the receiving Cervarix.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lymphadenopathy
Clinical narrative: swollen lymph nodes; chills; This case was reported by a consumer via call center representative and described the occurrence of inguinal lymph nodes enlarged in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced inguinal lymph nodes enlarged and chills. On an unknown date, the outcome of the inguinal lymph nodes enlarged and chills were unknown.   It was unknown if the reporter considered the inguinal lymph nodes enlarged and chills to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. More than 3 weeks ago from the date of reporting, the patient received Shingrix. The patient had swollen lymph nodes in groin and chills. The reporter was not sure if these were side effects of vaccine or something else and wanted to confirm the same.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th May 2019, the patient received the 2nd dose of Shingles vaccine. In May 2019, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient for himself. The age at vaccination was not reported. On 13th May 2019 yesterday from the reporting date, the patient had 2nd dose of Shingles vaccine. The patient was having a common side effects. The patient inquired, how long does the side effects last after the injection. This case has been linked with the case US2019GSK100392, reported for patient's wife.
Sex: F
Vaccine: MEN
Symptoms: Meningitis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningitis were unknown. It was unknown if the reporter considered the vaccination failure and meningitis to be related to Meningococcal B vaccine. Additional information was reported as follows: This case reported by the reporter's sister. The age at vaccination was not reported. The patient was fully vaccinated with Meningococcal B vaccine contracted this twice and the vaccines kill. This case was considered as suspected vaccination failure case since the details regarding laboratory confirmation and time to onset for target disease were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th May 2019, the patient received the 2nd dose of Shingles vaccine. In May 2019, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patients husband. The age at vaccination was not reported. On 13th May 2019 yesterday from the reporting date, the patient had 2nd dose of Shingles vaccine. The patient was having a common side effects. The patients husband inquired, how long does the side effects last after the injection. This case has been linked with the case US2019AMR096010, reported for patient's husband.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Left shoulder pain around actual humeral head; anterior, posterior, and superior since receiving  injection.  Limited AROM and PROM as well.  Patient did apply heat with minimal, temporary improvement.  PCP did evaluate on 5/31/19 where PT and Naproxen was prescribed.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Hand-foot-and-mouth disease, Incorrect dose administered, Pyrexia, Rash
Clinical narrative: Was inadvertently given adult dose of the vaccine.  Physician gave order for pediatric dose, then MA pulled adult dose out of refrigerator.  Second MA checked vaccine and okay'd the dose.  Incorrect dose then administered.  3 days later patient developed fever and rash.  Symptoms of fever and rash clinically looked mostly likely due to Hand-Foot-Mouth disease.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Concussion, Fall, Head injury
Clinical narrative: Fell hitting her head on the tile floor at check-out. Patient was transferred back to patient room to lay down and rest total time of roughly 30 min post episode. Reevaluated and diagnosed with mild concussion although exam findings were reassuring.  Initial BP  110/74, BP Post episode 122/80, BP at discharge 112/80.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Dehydration, Dizziness, Eye pain, Fatigue
Clinical narrative: Monday 5/13/19: Patient had vertigo in the afternoon. Parent thought she was dehydrated, so they gave her some water. Tuesday 5/14/19: Dizziness persisted off and on during the day. Then her eyes started feeling painful. Later that night she had eye pain, pain with movement and pressure, and frontal headache. She had 2 small lymph nodes on the back of her head. Wednesday 5/15/19: Eye pain and headache worse, new onset of fatigue, more lymph nodes. Crying at night, but the dizziness resolved. Thursday 5/16/19: Fatigue in the morning, pain in the eyes. Difficult to get patient to school; she wanted to lay around. Mom let her go to school late. That night patient said the eye pain was present, but it did not get worse late at night. Friday 5/17/19: Patient said she felt much better but in the morning mom saw that she had a full rash over her face and chest, with large submandibular lymph nodes bilaterally.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lymph node palpable, Lymphadenopathy, Rash, Vertigo
Clinical narrative: Monday 5/13/19: Patient had vertigo in the afternoon. Parent thought she was dehydrated, so they gave her some water. Tuesday 5/14/19: Dizziness persisted off and on during the day. Then her eyes started feeling painful. Later that night she had eye pain, pain with movement and pressure, and frontal headache. She had 2 small lymph nodes on the back of her head. Wednesday 5/15/19: Eye pain and headache worse, new onset of fatigue, more lymph nodes. Crying at night, but the dizziness resolved. Thursday 5/16/19: Fatigue in the morning, pain in the eyes. Difficult to get patient to school; she wanted to lay around. Mom let her go to school late. That night patient said the eye pain was present, but it did not get worse late at night. Friday 5/17/19: Patient said she felt much better but in the morning mom saw that she had a full rash over her face and chest, with large submandibular lymph nodes bilaterally.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; inadvertently administered an expired dose of MMR II; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 29-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) (lot # N014483 and expiration date 10-MAY-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 3 Patient were administered improperly stored; This spontaneous report as received from a registered nurse, concerning to a 4 month old patient of unknown gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On 20-MAY-2019, the patient was vaccinated with improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, anatomical location or route of administration were not provided); the nurse was unsure which lots had been administered if lot number R021650 with expiration date 27-MAY-2020 or lot number R021216 with expiration date 25-APR-2020. On the same date, the patient was also vaccinated with improperly stored of hib conj vaccine (ompc)(PEDVAXHIB) (strength, anatomical location or route of administration were not provided); the nurse was unsure which lots had been administered if lot number R021085 and expiration date  07-JUN-2021 or lot number R027321 and expiration date 09-JUL-2021. Both vaccines were administrated as prophylaxis. No adverse effects reported.          The storage temperature of the vaccine was reported as total time and highest temperature above 9 degrees Celsius (°C) (9.3 C, multiple excursions) for 1 hour and 45 minutes. There were no previous temperature excursions. The digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.; Sender's Comments:  US-009507513-1906USA000495: US-009507513-1906USA000496: US-009507513-1906USA000497:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 3 Patient were administered improperly stored; This spontaneous report as received from a registered nurse concerning to a 7 month old patient of unknown gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On 10-MAY-2019, the patient was vaccinated with improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, anatomical location or route of administration were not provided) for prophylaxis. The nurse was unsure which lots had been administered if lot number R021650 with expiration date 27-MAY-2020 or lot number R021216 with expiration date 25-APR-2020. No adverse effects reported.          The storage temperature of the vaccine was reported as total time and highest temperature above 9 degrees Celsius (°C) (9.3 C, multiple excursions) for 1 hour and 45 minutes. There were no previous temperature excursions. The digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.; Sender's Comments:  US-009507513-1906USA000487: US-009507513-1906USA000496: US-009507513-1906USA000497:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 3 Patient were administered improperly stored; This spontaneous report was received from  a registered nurse, concerning to a 8 week old patient of unknown gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On 07-MAY-2019, the patient was vaccinated with improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, route of administration were not provided); the nurse was unsure which lots had been administered if lot number R021650 with expiration date 27-MAY-2020 or lot number R021216 with expiration date 25-APR-2020. On the same date, the patient was also vaccinated with improperly stored of hib conj vaccine (ompc)(PEDVAXHIB) (strength, anatomical location or route of administration were not provided); the nurse was unsure which lots had been administered if lot number R021085 and expiration date  07-JUN-2021 or lot number R027321 and expiration date 09-JUL-2021. Both vaccines were administrated as prophylaxis. No adverse effects reported.          The storage temperature of the vaccine was reported as total time and highest temperature above 9 degrees Celsius (°C) (9.3 C, multiple excursions) for 1 hour and 45 minutes. There were no previous temperature excursions. The digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.; Sender's Comments:  US-009507513-1906USA000495: US-009507513-1906USA000487: US-009507513-1906USA000497: