chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Adverse reaction, Chest discomfort, Chills, Heart rate increased
Clinical narrative: Mom called health department at 1:15 on 7-9-18 and states that child is not acting right. States child is curled up in a ball, having chills but that she has not taken child's temperature. Mom states she has given child TYLENOL. Mom states child is having pain at injection site, fast heart rate, and tightness in chest. Mom states child has history of asthma. Education provided on VIS sheet for the vaccine and toll free VAERS number given. Instructed mom to take child to see MD as soon as possible. Supervisor notified. Mom called health department on 7-10-18 at 0835 and states that she took child to emergency room and was told that it was an adverse reaction. Mom states emergency room physician states that it was not an anaphylactic reaction due to no hives or swelling in throat. Mom states that child had severe pain in right shoulder on down into arm and no redness or swelling. Mom states that child was having fever and chills. Mom states child was given SOLU MEDROL, BENADRYL, and PEPCID. Mom states child also was given ATIVAN because child was having a panic attack and that child has a history of panic attacks. Emergency Room Physician states for child not to receive any more of the meningococcal B vaccines. Mom states she does not know how child is doing this AM because she left to go to work at 3 AM.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity, Panic attack, Pyrexia
Clinical narrative: Mom called health department at 1:15 on 7-9-18 and states that child is not acting right. States child is curled up in a ball, having chills but that she has not taken child's temperature. Mom states she has given child TYLENOL. Mom states child is having pain at injection site, fast heart rate, and tightness in chest. Mom states child has history of asthma. Education provided on VIS sheet for the vaccine and toll free VAERS number given. Instructed mom to take child to see MD as soon as possible. Supervisor notified. Mom called health department on 7-10-18 at 0835 and states that she took child to emergency room and was told that it was an adverse reaction. Mom states emergency room physician states that it was not an anaphylactic reaction due to no hives or swelling in throat. Mom states that child had severe pain in right shoulder on down into arm and no redness or swelling. Mom states that child was having fever and chills. Mom states child was given SOLU MEDROL, BENADRYL, and PEPCID. Mom states child also was given ATIVAN because child was having a panic attack and that child has a history of panic attacks. Emergency Room Physician states for child not to receive any more of the meningococcal B vaccines. Mom states she does not know how child is doing this AM because she left to go to work at 3 AM.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (lot # reported as N019282), expiration date 09-JAN-2019 and VARIVAX (lot # N021581), expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored Merck sterile diluent. Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 26-JAN-2018, the patient was vaccinated with improperly stored dose of PROQUAD (lot # N019828 (previously reported as N019282)), therapy type: recombinant human albumin (rHA), expiration date on 09-JAN-2019 and VARIVAX. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1806USA007938; US-009507513-1806USA007939; US-009507513-1806USA007940; US-009507513-1806USA007936; US-009507513-1801USA006139.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 29-JUN-2018, the patient was vaccinated with M-M-R II injection (lot # M048036, expiration date 08-DEC-2018) via intramuscular route of administration for prophylaxis. Concomitant therapy included sterile diluent which was used for reconstitution of M-M-R II and was properly stored. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2013, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-AUG-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-DEC-2012, the patient was treated by a physician assistant for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed FAMVIR for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Injection was on 6/21/18. She had a large red area on left arm that became swollen, hard, and painful within 24 hours of the injection (6/22/18). The swelling started decreasing around 6/24 - 6/25. The area progressively became purple and softer. On 6/28/2018, she started taking ibuprofen every 8hrs to stop pain and itching in arm. The arm felt better with taking ibuprofen and the area started to fade.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Injection was on 6/21/18. She had a large red area on left arm that became swollen, hard, and painful within 24 hours of the injection (6/22/18). The swelling started decreasing around 6/24 - 6/25. The area progressively became purple and softer. On 6/28/2018, she started taking ibuprofen every 8hrs to stop pain and itching in arm. The arm felt better with taking ibuprofen and the area started to fade.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Shivering, bodyaches, headache.
Age: 31.0
Sex: F
Vaccine: ANTH, IPV, TYP
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site discomfort, Injection site erythema
Clinical narrative: On 03 July she developed redness, swelling, itching and discomfort to upper arm where she received AVA and typhoid. Area the size of her palm going around the arm. No swelling to elbow. This was AVA number 5. No problems with previous immz. July, in addition to above symptoms she also report flu like symptoms, headache and joint pain. Denies fever. Follow up on 06 July and reported improvement of symptoms Follow up 09 July and she reports that symptoms have almost fully resolved and she is feeling much better. Continues with some soreness to her arms and localized itching.
Age: 31.0
Sex: F
Vaccine: ANTH, IPV, TYP
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: On 03 July she developed redness, swelling, itching and discomfort to upper arm where she received AVA and typhoid. Area the size of her palm going around the arm. No swelling to elbow. This was AVA number 5. No problems with previous immz. July, in addition to above symptoms she also report flu like symptoms, headache and joint pain. Denies fever. Follow up on 06 July and reported improvement of symptoms Follow up 09 July and she reports that symptoms have almost fully resolved and she is feeling much better. Continues with some soreness to her arms and localized itching.
Age: 75.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: Pain in right arm began within days of SHINGRIX vaccine. Pain continues currently, radiates down right arm, through elbow. Pain disrupts sleep and daily activities.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient states her arm was red, hot, swollen, and hard around the site of injection the evening that she received the vaccination. She went to urgent care and received a prescription for prednisone and an antibiotic. She then went to see her family practitioner about the incident. After receiving treatment it took one week for symptoms to resolve.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Chills, Metabolic function test normal, Red blood cell sedimentation rate normal
Clinical narrative: Chills in the initial 24 hours, followed by arthralgias which have diminished, but are still present three months later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Joint pain, headache, fever, nausea, muscle pain - still occurring.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Discomfort, Flank pain, Impaired driving ability
Clinical narrative: We both received the first dose of the Recombinant Zoster (Shingles) Vaccine on June 20, 2018, at Dr. office. We received the Vaccine Information Statement when we left the office, but were not advised about any possible severe side effects prior to receiving the vaccine. That night neither of us slept well because of severe soreness in our arms, where the shot was administered. Spouse had fever, chills, and nausea. Because patient was driving, we went forward with our plans for the following day, to leave to visit our daughter and her family, a distance of about 540 miles. That afternoon patient developed severe chills and nausea, severe enough that he did not want to continue to drive. We stopped about half way to our destination, both took a four hour nap, had a small supper, and went back to sleep for twelve hours. During that time patient continued to have severe chills. The following day (June 21) we both continued to have extremely sore arms but felt somewhat better, so we completed our trip. We drive home on June 25 and 26. On Saturday, June 30, patient continued to experience flu-like symptoms, which he described saying, "I feel the same way I felt the day after getting the Shingles shot." He also had a deep, hard cough, and complained of having a swollen right leg and pain in his left side. On the following day, Sunday, July 1, he was so uncomfortable with those symptoms that we went to a walk-in clinic near our home. The physician at the walk-in clinic advised patient to go the ER. There he was diagnosed with blood clots in his right leg and both lungs, Pulmonary Embolism, and was hospitalized until the afternoon of July 5th. Did the Pulmonary Embolism occur because patient, as a result of the vaccine, slept for so long at the motel on June 21? Perhaps became dehydrated and didn't move around much? Or was it because we had embarked on a long road trip, as we had done many times before? Patient feels strongly that the PE was, at least in part, a result of side effects of the Shingles vaccine. When we arrived at the E.R., the first thing the attending physician asked was, "Have you taken a long trip? Have you been inactive for any reason?" The inactivity occurred when we slept for sixteen hours at the motel. That was directly a result of us receiving the Shingles vaccine. Now we are questioning, should we get the follow-up vaccine when we are due to have it, or should we choose not to have it? Thank you for your attention to our concern.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: We both received the first dose of the Recombinant Zoster (Shingles) Vaccine on June 20, 2018, at Dr. office. We received the Vaccine Information Statement when we left the office, but were not advised about any possible severe side effects prior to receiving the vaccine. That night neither of us slept well because of severe soreness in our arms, where the shot was administered. Spouse had fever, chills, and nausea. Because patient was driving, we went forward with our plans for the following day, to leave to visit our daughter and her family, a distance of about 540 miles. That afternoon patient developed severe chills and nausea, severe enough that he did not want to continue to drive. We stopped about half way to our destination, both took a four hour nap, had a small supper, and went back to sleep for twelve hours. During that time patient continued to have severe chills. The following day (June 21) we both continued to have extremely sore arms but felt somewhat better, so we completed our trip. We drive home on June 25 and 26. On Saturday, June 30, patient continued to experience flu-like symptoms, which he described saying, "I feel the same way I felt the day after getting the Shingles shot." He also had a deep, hard cough, and complained of having a swollen right leg and pain in his left side. On the following day, Sunday, July 1, he was so uncomfortable with those symptoms that we went to a walk-in clinic near our home. The physician at the walk-in clinic advised patient to go the ER. There he was diagnosed with blood clots in his right leg and both lungs, Pulmonary Embolism, and was hospitalized until the afternoon of July 5th. Did the Pulmonary Embolism occur because patient, as a result of the vaccine, slept for so long at the motel on June 21? Perhaps became dehydrated and didn't move around much? Or was it because we had embarked on a long road trip, as we had done many times before? Patient feels strongly that the PE was, at least in part, a result of side effects of the Shingles vaccine. When we arrived at the E.R., the first thing the attending physician asked was, "Have you taken a long trip? Have you been inactive for any reason?" The inactivity occurred when we slept for sixteen hours at the motel. That was directly a result of us receiving the Shingles vaccine. Now we are questioning, should we get the follow-up vaccine when we are due to have it, or should we choose not to have it? Thank you for your attention to our concern.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pulmonary embolism, Thrombosis
Clinical narrative: We both received the first dose of the Recombinant Zoster (Shingles) Vaccine on June 20, 2018, at Dr. office. We received the Vaccine Information Statement when we left the office, but were not advised about any possible severe side effects prior to receiving the vaccine. That night neither of us slept well because of severe soreness in our arms, where the shot was administered. Spouse had fever, chills, and nausea. Because patient was driving, we went forward with our plans for the following day, to leave to visit our daughter and her family, a distance of about 540 miles. That afternoon patient developed severe chills and nausea, severe enough that he did not want to continue to drive. We stopped about half way to our destination, both took a four hour nap, had a small supper, and went back to sleep for twelve hours. During that time patient continued to have severe chills. The following day (June 21) we both continued to have extremely sore arms but felt somewhat better, so we completed our trip. We drive home on June 25 and 26. On Saturday, June 30, patient continued to experience flu-like symptoms, which he described saying, "I feel the same way I felt the day after getting the Shingles shot." He also had a deep, hard cough, and complained of having a swollen right leg and pain in his left side. On the following day, Sunday, July 1, he was so uncomfortable with those symptoms that we went to a walk-in clinic near our home. The physician at the walk-in clinic advised patient to go the ER. There he was diagnosed with blood clots in his right leg and both lungs, Pulmonary Embolism, and was hospitalized until the afternoon of July 5th. Did the Pulmonary Embolism occur because patient, as a result of the vaccine, slept for so long at the motel on June 21? Perhaps became dehydrated and didn't move around much? Or was it because we had embarked on a long road trip, as we had done many times before? Patient feels strongly that the PE was, at least in part, a result of side effects of the Shingles vaccine. When we arrived at the E.R., the first thing the attending physician asked was, "Have you taken a long trip? Have you been inactive for any reason?" The inactivity occurred when we slept for sixteen hours at the motel. That was directly a result of us receiving the Shingles vaccine. Now we are questioning, should we get the follow-up vaccine when we are due to have it, or should we choose not to have it? Thank you for your attention to our concern.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pyrexia
Clinical narrative: On 07/06/18, pt presented to Clinic for evaluation of nocturia. During visit, pt reported that she received the SHINGRIX vaccination (varicella zoster vaccine) on 06/29/18 (vaccine location not disclosed or documented). Pt reported that after injection she developed soreness in left arm with a rash at injection site as well as fever (which may or may not have been related). Symptoms completely resolved without incident. No further information is available. Per the SHINGRIX prescribing information: "The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach". This appears to have been the first of the 2 injection series.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, HEP, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on arms.
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: DTAP was ordered, TDAP was mistakenly given.  Patient did not have any adverse reaction. Physician was notified.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. On 08-MAY-2018 the patient was vaccinated with unspecified shingles vaccine (manufacturer unknown) subcutaneous for prophylaxis. On 2018 the patient experienced adverse event. The outcome of adverse event is unknown.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Crying, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 12-JUN-2018 at 10:00, the patient was vaccinated with a partial dose of VARIVAX (lot # and expiration date were not reported) subcutaneously for prophylaxis. Sterile diluent (lot # and expiration date were not reported) was used to reconstitute VARIVAX. The patient was crying and moved away as the vaccine was being administered and only about 0.25mL of the vaccine was given to the patient. No adverse effects were reported. Therapy was not discontinued.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. In 2012, the patient was inoculated with the ZOSTAVAX at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. In 2015, the patient was treated by a physician's assistant, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2016, the patient was treated for vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2014, the patient was treated by a physician for vesicular outbreak, which was diagnosed as shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient came to pharmacy the day after receiving the vaccine with a complaints of a sore arm. He showed me the vaccine site, it was red, warm to the touch, and sore. He said he just wanted to make sure it was nothing to be concerned about.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Muscle and joint aches, dizzy, tired, nausea, headache, mild.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Muscle and joint aches, dizzy, tired, nausea, headache, mild.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Cough, Crying, Decreased appetite, Irritability, Nasal congestion
Clinical narrative: 101.4 fever for two days, chest cough, irritation, crying, stuffy nose and cough continued for 6 days, loss of appetite for 5 days.
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: 101.4 fever for two days, chest cough, irritation, crying, stuffy nose and cough continued for 6 days, loss of appetite for 5 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Extreme fatigue started immediately and has lasted two weeks plus she has developed a pain or burning under shoulder blade that worsens as she lies in bed overnight.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Chest X-ray normal, Chills, Culture urine negative, Diarrhoea
Clinical narrative: 6/27/2018-Patient came to this Employee health RN on 6/27/18 at 9:00am and reported that she believes she had a reaction to the Hepatitis B vaccine she received. She reports that on the afternoon after receiving the injection her right gland was swollen and sore. This resolved by that evening, but then she developed a headache, fever, chills, and cramps in her right leg. These symptoms continue through until today, with the exception of the leg cramps which resolved that night. Her fever has also been controlled with TYLENOL per patient. She went to the ER at Hospital on Sunday 6/24/2018 and was told she had a 103 degree fever (she was unaware what her temperature was prior to & after that as has not checked it). They performed an EKG, Chest x-ray and labs (including urine culture) at ER per patient and she was told all was negative and clear and that she likely had an unrelated virus. She made an appointment with her PCP for 7/12/2018 as this was soonest she could get in to see her based on MD schedule and her work schedule. Patient also reports to have a feeling of her head feeling foggy and a jittery feeling. She has not had any BM since day of vaccine, with exception of small loose stool yesterday. She reports no cough or sore throat, no Nausea or vomiting and no trouble swallowing or breathing. She also reports to have a normal appetite. On 6/26/2018 she noted a rash area under her left arm. This RN observed area and was a flat round reddened area (hive-like), that did not feel warm to the touch. Patient reports area is itchy, but no other reddened areas noted. This RN spoke with Infection Control manager at Hospital and she reports to discuss symptoms with Pharmacy. This RN then spoke with staff in the pharmacy, sharing all of patient's symptoms and she reports it sounds to her like an adverse reaction, but not an allergic reaction and the rash can develop 7-10 days after vaccine as a delayed response. Patient was made aware that if she feels ill/feverish she should not be working and she stated she was not feverish at this time. RN also encouraged her to call for earlier appt with PCP and to go to Walk-in or ER if needed sooner. 7/2/2018-Call placed to patient's department in hospital, spoke with dietitian, and she reports patient is not working today. RN then called patient at home number and left a message. 7/3/2018-Call placed again to patient's department in hospital, message left for Director to have patient come see Employee Health or call. 7/5/2018-Patient came to Employee Health and reports that she has improved overall, but in evening still gets chills, so assumes has a fever then, but has not checked with a thermometer. She has taken TYLENOL with good effect on chills. Patient also reports that her reddened hive-like areas have increased and are now up and down both arms. No trouble swallowing or breathing per patient. Patient continues with scheduled appt with PCP on 7/12/2018 and has not needed to return to ER.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Electrocardiogram normal, Feeling abnormal, Feeling jittery, Headache, Lymph node pain
Clinical narrative: 6/27/2018-Patient came to this Employee health RN on 6/27/18 at 9:00am and reported that she believes she had a reaction to the Hepatitis B vaccine she received. She reports that on the afternoon after receiving the injection her right gland was swollen and sore. This resolved by that evening, but then she developed a headache, fever, chills, and cramps in her right leg. These symptoms continue through until today, with the exception of the leg cramps which resolved that night. Her fever has also been controlled with TYLENOL per patient. She went to the ER at Hospital on Sunday 6/24/2018 and was told she had a 103 degree fever (she was unaware what her temperature was prior to & after that as has not checked it). They performed an EKG, Chest x-ray and labs (including urine culture) at ER per patient and she was told all was negative and clear and that she likely had an unrelated virus. She made an appointment with her PCP for 7/12/2018 as this was soonest she could get in to see her based on MD schedule and her work schedule. Patient also reports to have a feeling of her head feeling foggy and a jittery feeling. She has not had any BM since day of vaccine, with exception of small loose stool yesterday. She reports no cough or sore throat, no Nausea or vomiting and no trouble swallowing or breathing. She also reports to have a normal appetite. On 6/26/2018 she noted a rash area under her left arm. This RN observed area and was a flat round reddened area (hive-like), that did not feel warm to the touch. Patient reports area is itchy, but no other reddened areas noted. This RN spoke with Infection Control manager at Hospital and she reports to discuss symptoms with Pharmacy. This RN then spoke with staff in the pharmacy, sharing all of patient's symptoms and she reports it sounds to her like an adverse reaction, but not an allergic reaction and the rash can develop 7-10 days after vaccine as a delayed response. Patient was made aware that if she feels ill/feverish she should not be working and she stated she was not feverish at this time. RN also encouraged her to call for earlier appt with PCP and to go to Walk-in or ER if needed sooner. 7/2/2018-Call placed to patient's department in hospital, spoke with dietitian, and she reports patient is not working today. RN then called patient at home number and left a message. 7/3/2018-Call placed again to patient's department in hospital, message left for Director to have patient come see Employee Health or call. 7/5/2018-Patient came to Employee Health and reports that she has improved overall, but in evening still gets chills, so assumes has a fever then, but has not checked with a thermometer. She has taken TYLENOL with good effect on chills. Patient also reports that her reddened hive-like areas have increased and are now up and down both arms. No trouble swallowing or breathing per patient. Patient continues with scheduled appt with PCP on 7/12/2018 and has not needed to return to ER.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Muscle spasms, Pyrexia, Rash, Rash erythematous
Clinical narrative: 6/27/2018-Patient came to this Employee health RN on 6/27/18 at 9:00am and reported that she believes she had a reaction to the Hepatitis B vaccine she received. She reports that on the afternoon after receiving the injection her right gland was swollen and sore. This resolved by that evening, but then she developed a headache, fever, chills, and cramps in her right leg. These symptoms continue through until today, with the exception of the leg cramps which resolved that night. Her fever has also been controlled with TYLENOL per patient. She went to the ER at Hospital on Sunday 6/24/2018 and was told she had a 103 degree fever (she was unaware what her temperature was prior to & after that as has not checked it). They performed an EKG, Chest x-ray and labs (including urine culture) at ER per patient and she was told all was negative and clear and that she likely had an unrelated virus. She made an appointment with her PCP for 7/12/2018 as this was soonest she could get in to see her based on MD schedule and her work schedule. Patient also reports to have a feeling of her head feeling foggy and a jittery feeling. She has not had any BM since day of vaccine, with exception of small loose stool yesterday. She reports no cough or sore throat, no Nausea or vomiting and no trouble swallowing or breathing. She also reports to have a normal appetite. On 6/26/2018 she noted a rash area under her left arm. This RN observed area and was a flat round reddened area (hive-like), that did not feel warm to the touch. Patient reports area is itchy, but no other reddened areas noted. This RN spoke with Infection Control manager at Hospital and she reports to discuss symptoms with Pharmacy. This RN then spoke with staff in the pharmacy, sharing all of patient's symptoms and she reports it sounds to her like an adverse reaction, but not an allergic reaction and the rash can develop 7-10 days after vaccine as a delayed response. Patient was made aware that if she feels ill/feverish she should not be working and she stated she was not feverish at this time. RN also encouraged her to call for earlier appt with PCP and to go to Walk-in or ER if needed sooner. 7/2/2018-Call placed to patient's department in hospital, spoke with dietitian, and she reports patient is not working today. RN then called patient at home number and left a message. 7/3/2018-Call placed again to patient's department in hospital, message left for Director to have patient come see Employee Health or call. 7/5/2018-Patient came to Employee Health and reports that she has improved overall, but in evening still gets chills, so assumes has a fever then, but has not checked with a thermometer. She has taken TYLENOL with good effect on chills. Patient also reports that her reddened hive-like areas have increased and are now up and down both arms. No trouble swallowing or breathing per patient. Patient continues with scheduled appt with PCP on 7/12/2018 and has not needed to return to ER.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic, Urticaria, Vaccination complication, Viral infection
Clinical narrative: 6/27/2018-Patient came to this Employee health RN on 6/27/18 at 9:00am and reported that she believes she had a reaction to the Hepatitis B vaccine she received. She reports that on the afternoon after receiving the injection her right gland was swollen and sore. This resolved by that evening, but then she developed a headache, fever, chills, and cramps in her right leg. These symptoms continue through until today, with the exception of the leg cramps which resolved that night. Her fever has also been controlled with TYLENOL per patient. She went to the ER at Hospital on Sunday 6/24/2018 and was told she had a 103 degree fever (she was unaware what her temperature was prior to & after that as has not checked it). They performed an EKG, Chest x-ray and labs (including urine culture) at ER per patient and she was told all was negative and clear and that she likely had an unrelated virus. She made an appointment with her PCP for 7/12/2018 as this was soonest she could get in to see her based on MD schedule and her work schedule. Patient also reports to have a feeling of her head feeling foggy and a jittery feeling. She has not had any BM since day of vaccine, with exception of small loose stool yesterday. She reports no cough or sore throat, no Nausea or vomiting and no trouble swallowing or breathing. She also reports to have a normal appetite. On 6/26/2018 she noted a rash area under her left arm. This RN observed area and was a flat round reddened area (hive-like), that did not feel warm to the touch. Patient reports area is itchy, but no other reddened areas noted. This RN spoke with Infection Control manager at Hospital and she reports to discuss symptoms with Pharmacy. This RN then spoke with staff in the pharmacy, sharing all of patient's symptoms and she reports it sounds to her like an adverse reaction, but not an allergic reaction and the rash can develop 7-10 days after vaccine as a delayed response. Patient was made aware that if she feels ill/feverish she should not be working and she stated she was not feverish at this time. RN also encouraged her to call for earlier appt with PCP and to go to Walk-in or ER if needed sooner. 7/2/2018-Call placed to patient's department in hospital, spoke with dietitian, and she reports patient is not working today. RN then called patient at home number and left a message. 7/3/2018-Call placed again to patient's department in hospital, message left for Director to have patient come see Employee Health or call. 7/5/2018-Patient came to Employee Health and reports that she has improved overall, but in evening still gets chills, so assumes has a fever then, but has not checked with a thermometer. She has taken TYLENOL with good effect on chills. Patient also reports that her reddened hive-like areas have increased and are now up and down both arms. No trouble swallowing or breathing per patient. Patient continues with scheduled appt with PCP on 7/12/2018 and has not needed to return to ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Patient reported flu like symptoms with fever of 101 and injection site pain.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Client stated that she started to have redness and warmth in her left arm approximately 2-3 days following the vaccine being given, she then stated that the redness and warm sensation started to spread down her left arm and then she started to notice the same reaction on her chest and neck. Client stated that she took over the counter BENADRYL x4 doses and the reaction went away.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nerve conduction studies
Clinical narrative: About a week after getting the flu shot, I ended up getting AIDP (Acute Inflammatory Demyelinating Polyneuropathy)-AKA GBS.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: About a week after getting the flu shot, I ended up getting AIDP (Acute Inflammatory Demyelinating Polyneuropathy)-AKA GBS.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Soft tissue swelling
Clinical narrative: Prolonged localized soft tissue swelling.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Echocardiogram normal, Electrocardiogram normal, Face injury, Syncope
Clinical narrative: Syncope from sitting position after administration of HPV. Hit face on desk and (L) cheek contusion no dental or mycosal trauma.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Rash macular
Clinical narrative: Blotches were noticed on the back of Pt. several hours after MMR-V was given.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus infection, Psoriasis, Rash, Rash erythematous, Urticaria
Clinical narrative: Large red bumps (center chest). Herpes sores around groin. Hives on lower back. Psoriasis legs.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pruritus
Clinical narrative: Person developed severe itchy skin. No hives. Unable to sleep. Took BENADRYL and ZYRTEC. Itchiness is slowly resolving.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Person developed severe itchy skin. No hives. Unable to sleep. Took BENADRYL and ZYRTEC. Itchiness is slowly resolving.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed Shingles approximately 8-10 days after receiving SHINGRIX.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Poor quality sleep
Clinical narrative: Joint pains, poor appetite, fatigue, poor sleep for 2 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Achy, tired-sleepy, minimal pruritus-forearms/lower legs, rash-sides of neck, shoulders, upper back, left arm pain from 7-5-18 to 7-8-18. Prednisone 20mg 1 tablet by mouth daily for 5 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Achy, tired-sleepy, minimal pruritus-forearms/lower legs, rash-sides of neck, shoulders, upper back, left arm pain from 7-5-18 to 7-8-18. Prednisone 20mg 1 tablet by mouth daily for 5 days.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Burning sensation, Flushing, Headache, Neck pain, Pain
Clinical narrative: Pt. C/O HA in both temples rated at 6/10 - throbbing pain that continues. The pt. is also feeling febrile and developed neck pain with flexing neck. Per pt, Sx developed 15 minutes after receiving the PREVNAR-13 vaccination. He also stated that he had flushing in the face with a burning sensation that has subsided after taking BENADRYL. Patient presented to the ER.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Pt. C/O HA in both temples rated at 6/10 - throbbing pain that continues. The pt. is also feeling febrile and developed neck pain with flexing neck. Per pt, Sx developed 15 minutes after receiving the PREVNAR-13 vaccination. He also stated that he had flushing in the face with a burning sensation that has subsided after taking BENADRYL. Patient presented to the ER.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt. received extra dose of MENACTRA. Patient's first dose was 7/18/2012 and second dose was 02/20/2018. Patient received an additional dose on 7/10/2018. No adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Lung infection, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-APR-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles and zoster-related illnesses. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On an unknown date in 2013, the patient was treated at a hospital for an infection in the lungs caused by a varicella virus, which was diagnosed as (varicella) pneumonia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The patient suffered from herpes zoster and zoster-related pneumonia, with painful and persistent physical injuries and damages, and other serious injuries as a direct and proximate result of being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result, the patient suffered severe and permanent personal injuries, including significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient suffered, is suffering, and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her physical conditions. (Varicella) pneumonia, ZOSTAVAX did not prevent shingles as intended, and persistent strain of herpes zoster/shingles were considered to be disabling. Upon internal review, (varicella) pneumonia was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 15-SEP-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.