chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC13, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was given additional IPV after PEDIARIX given. No injuries or adverse outcomes.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure fluctuation, Delirium, Lethargy, Tremor, Vomiting
Clinical narrative: Uncontrollable shaking, vomiting, lethargy, blood pressure up and down, delirium.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Lip swelling, Rash
Clinical narrative: The following morning after the patient received her shot, she said she felt like something was "stuck in her chest." On Thursday, her bottom lip started swelling, she broke out in a rash on her arms, and she started having shortness of breath and wheezing. She went to the ER on Thursday where she was told that she had an allergy to the SHINGRIX shot most likely. She has not had any allergies that she was aware of. She will be getting allergy testing in the coming weeks to confirm her allergy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: The following morning after the patient received her shot, she said she felt like something was "stuck in her chest." On Thursday, her bottom lip started swelling, she broke out in a rash on her arms, and she started having shortness of breath and wheezing. She went to the ER on Thursday where she was told that she had an allergy to the SHINGRIX shot most likely. She has not had any allergies that she was aware of. She will be getting allergy testing in the coming weeks to confirm her allergy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 46.0
Sex: M
Vaccine: HEP, HIBV, IPV, MMR, PPV, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: According to the order on Nov/7/2017 noted there was a list of vaccinations recommended by Dr which were not clear and after communication with Dr, he advised the patient get following vaccines, the Hep B, MMR, HIB, PSV 23, IPV, varicella and polio. Verified with another nurse the vaccines. After the vaccines given noticed that instead of varicella SHINGRIX vaccine was given. Notified the DR and he stated that the vaccine is no danger to patient. The patient had No contraindications to the vaccine. Dr said he will call the patient and I reported this to my supervisor. The pt was fine and no adverse effect.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Computerised tomogram head, Electroencephalogram, Febrile convulsion, Full blood count, Generalised tonic-clonic seizure
Clinical narrative: Previously healthy child,had 4 vaccines at 10 am tomorrow and 4.5 hours later at 2:30 pm had a 5-6 minute tonic clonic seizure. Went to ER, had normal head CT without contrast, normal bone survey, all labs normal. The day of admission 5/2, child was taken to urgent care for follow-up, and started seizing. The character of the seizure as similar as previous, and lasted 5 - 6 minutes with a post-ictal period. She was subsequently transferred to hospital for admission. She was afebrile, O2 sat 99% on RA, seizure ended and no new fevers yesterday, no new seizures during admission. EEG and MRI normal; discharged with diazepam 2.5mg kit to give rectally if seizure lasts 3 minutes or longer.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Previously healthy child,had 4 vaccines at 10 am tomorrow and 4.5 hours later at 2:30 pm had a 5-6 minute tonic clonic seizure. Went to ER, had normal head CT without contrast, normal bone survey, all labs normal. The day of admission 5/2, child was taken to urgent care for follow-up, and started seizing. The character of the seizure as similar as previous, and lasted 5 - 6 minutes with a post-ictal period. She was subsequently transferred to hospital for admission. She was afebrile, O2 sat 99% on RA, seizure ended and no new fevers yesterday, no new seizures during admission. EEG and MRI normal; discharged with diazepam 2.5mg kit to give rectally if seizure lasts 3 minutes or longer.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Rash
Clinical narrative: Rash and bruise.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Insomnia, Pyrexia, Rash
Clinical narrative: Pt developed a rash all around the upper arm, experienced trouble sleeping for 2 nights along with fever and chills.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased activity, Influenza like illness, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt states "flu-like reaction", decreased physical activity and use of arm due to extreme pain. Fever. Tennis ball size redness around injection site with swelling. Instructed her to call her physician as well.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt states "flu-like reaction", decreased physical activity and use of arm due to extreme pain. Fever. Tennis ball size redness around injection site with swelling. Instructed her to call her physician as well.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Herpes zoster, Injection site rash, Musculoskeletal pain, Neck pain
Clinical narrative: Patient called me on Sunday reporting severe pain in her shoulder and neck and a rash that had developed near the injection site. She reported treating the pain with ibuprofen, acetaminophen, and hydrocodone. She was seen by her primary care physician the next day (Monday), who diagnosed the patient with an acute case of Shingles caused by her immune system being "preoccupied" with building immunity to the Hepatitis A vaccination.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site joint pain, Pain, Paraesthesia
Clinical narrative: Pt developed pain in his shoulder joint and could not lift left shoulder up without extreme pain that radiated down his arm. He also mentioned tingling in his 4th and 5th fingers that resolved shortly after starting. When I talked with him, the pain was improving. Patient wonders if this is related to being on Evolocumab.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site redness, pain, warm, red, swelling, "hard rock" under the skin and itchy.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Site redness, pain, warm, red, swelling, "hard rock" under the skin and itchy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo positional
Clinical narrative: BPPV.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Red rash that "tracks" down the arm. There is no pain unless pressure but the rash is warm. The rash has a roughly 8 in diameter.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Having serious Hives all over body, since 2nd day of Vaccination, taken Allergy medicine will result temporary relief, but continuously in 12 hours will have hives again.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: REDNESS AT SITE AND FLU LIKE SYMPTOMS THAT EVENING AND NEXT DAY.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that the evening after receiving SHINGRIX (5/4/18) she experienced a red, puffy raised area at the injection site on her left arm, about 3/4 the size of a hand print, as well as tenderness at the injection site. She reported the reaction on Monday, 5/7, and stated that the swelling, redness, and tenderness had subsided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: After going to bed, had headache, shivering, fever and stomach pain. I took some TYLENOL and the shivering and fever subsided. The headache remained for a couple of days. Arm was sore for 6 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope
Clinical narrative: As I left pharmacy after shot I felt like I could pass out. I was able to keep walking and the feeling passed. 2 days later, I was playing golf. I again felt like a cold pass out. I need to sit down and call for a ride home. As I am a runner, I do not consider golf strenuous exercise.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Migraine with aura, Pain
Clinical narrative: Friday PM patient felt run down and tired body aches and pain lasting till Saturday. Sunday AM migraine with aura.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient came back to pharmacy at about 5:30 PM on 05/07/2018 with a sore arm with redness and swelling at the injection site. Said she's been putting ice on it but still not better. RPH gave her an icepack to put on it and called the Dr. right away. The covering doctor Dr. called back later and said to have the patient come in the next day to see if she needed an antibiotic. Rph told patient to do so after explaining what the doctor said. Also suggested was to take anti inflammatory in the interim till the next am and ice it also. Patient felt she didn't need to go to the ER and said will contact Dr. the next day. Rph will followup with MD and patient again .
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Pyrexia
Clinical narrative: Huge red area, lasting at least 3 days and getting bigger, fever, chills, joint pain worse than usual, terrible fatigue.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever on day following injection which subsided within 24 hours, then on May 6, left arm broke out in hives.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, fatigue, body aches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Few days after the shot, redness increased in size, and lower part of reaction had swelling (swelling started around week 2), and started itching. The increase in intensity occurred for approximately 2 weeks then started to decrease. By 5/7/18 (when patient reported reaction), appearance of the outline of the reaction is still visible. size of outline (4 inches by 2.5 inches).
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Condition aggravated, Dizziness, Headache, Injection site pain
Clinical narrative: Following day, sore arm at injection site. After 24 hours, extreme headache. Intermittent extreme headaches for 4 days. Lack of energy, dizziness, extreme exacerbation of chronic sciatic pain.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Sciatica
Clinical narrative: Following day, sore arm at injection site. After 24 hours, extreme headache. Intermittent extreme headaches for 4 days. Lack of energy, dizziness, extreme exacerbation of chronic sciatic pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Red, raised, swollen, painful, hot to touch. On 5/7/18 area was 4 inches X 3 1/4 inch oval and still growing. Fever of 101 F.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea, Throat irritation
Clinical narrative: Patient arrived at office for Varicella vaccine. Vaccine administered at 1:45 PM. Approximately 10 min after patient told medical staff that she was experiencing "chest tightness" and itching in her throat. Patient stated she felt like it was difficult to breath. Medical staff took vitals immediately with BP of 111/73 and Pulse 73 and alerted myself. Patient was able to speak in full sentences when talking to her. Visual inspection did not show any signs of angioedema, cyanosis, and no audible wheezing was heard. Upon physical examination there was no swelling of face, lips, or throat. Auscultation of lungs revealed bilateral wheezing. Patient stated she has allergic asthma but did not have her inhaler. Recommended to patient that I would like to give her IM Diphenhydramine 1 mL (50mg/ml) but patient initially declined and wanted to wait a few more minutes because BENADRYL makes her extremely drowsy. Waited a few minutes and reassessed BP 105/65, Pulse 73 and patient still did not feel better. Recommended Diphenhydramine again and patient agreed, but when i recommended she also go to the ER she refused. Told her we were going to call anyway. Administered Diphenhydramine IM at 245 PM. EMS called at 230 PM. A few minutes after administration patient said she felt better and the tightness in her chest was somewhat relieved. EMS evaluated patient and she declined, risks up to and including death explained to patient and she verbalized understanding. Patient remained in office for another 10-15 minutes and as time passed she felt more and more "relaxed". Patient's fiance came and picked her up. Told patient if she experiences any changes or gets worse to immediately go to the ER. Told patient she is never again to have a Varicella vaccine. Patient verbalizes understanding.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Patient arrived at office for Varicella vaccine. Vaccine administered at 1:45 PM. Approximately 10 min after patient told medical staff that she was experiencing "chest tightness" and itching in her throat. Patient stated she felt like it was difficult to breath. Medical staff took vitals immediately with BP of 111/73 and Pulse 73 and alerted myself. Patient was able to speak in full sentences when talking to her. Visual inspection did not show any signs of angioedema, cyanosis, and no audible wheezing was heard. Upon physical examination there was no swelling of face, lips, or throat. Auscultation of lungs revealed bilateral wheezing. Patient stated she has allergic asthma but did not have her inhaler. Recommended to patient that I would like to give her IM Diphenhydramine 1 mL (50mg/ml) but patient initially declined and wanted to wait a few more minutes because BENADRYL makes her extremely drowsy. Waited a few minutes and reassessed BP 105/65, Pulse 73 and patient still did not feel better. Recommended Diphenhydramine again and patient agreed, but when i recommended she also go to the ER she refused. Told her we were going to call anyway. Administered Diphenhydramine IM at 245 PM. EMS called at 230 PM. A few minutes after administration patient said she felt better and the tightness in her chest was somewhat relieved. EMS evaluated patient and she declined, risks up to and including death explained to patient and she verbalized understanding. Patient remained in office for another 10-15 minutes and as time passed she felt more and more "relaxed". Patient's fiance came and picked her up. Told patient if she experiences any changes or gets worse to immediately go to the ER. Told patient she is never again to have a Varicella vaccine. Patient verbalizes understanding.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Amino acid level, Blood creatine phosphokinase, Blood lactic acid, Blood pyruvic acid, Blood thyroid stimulating hormone
Clinical narrative: After receiving the MMR Vaccine on May 11, 2017, patient slowly slipped away into what seemed to be a mind fog. He stopped giving eye contact and developed a severe complex motor stereotypy. Prior to May 11, 2017, patient met all his milestones, socially, with speech and interactively as well as normal eating habits. After the MMR vaccine patient regressed in his development socially, interactively, eating habits and also in his speech. He now sees a Neuromuscular Specialist and has a developmental delay as well as a speech delay. Once we realized that patient has developed these delays his pediatrician referred patient to begin speech therapy. It took a few months to begin this process. Patient's speech therapist is strongly recommending Occupational Therapy for patient's other developmental delay. However, the state strongly discourages more than one therapy given and only prefers that one therapy per week. Speech Therapy is a funded program through the state, however because patient does not have insurance, therefore we have to pay a percentage of each speech therapy visit. We cannot afford private Occupational Therapy treatment at this time. Mother (myself) has also found the Protocol and began that in January to help heal the brain/gut injury due to the MMR vaccine. As time went on from May 11, 2017 and watching patient slip away to this mental fog and regress in his already met milestones has been one of the scariest things I've ever seen as a parent. Watching videos recorded and picture taken of patient prior to the MMR vaccine and seeing his normal behavior and eye contact and interactions and love for various foods back then eat breaks a mother's heart.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Decreased eye contact, Developmental delay, Developmental regression, Feeling abnormal, Metabolic function test
Clinical narrative: After receiving the MMR Vaccine on May 11, 2017, patient slowly slipped away into what seemed to be a mind fog. He stopped giving eye contact and developed a severe complex motor stereotypy. Prior to May 11, 2017, patient met all his milestones, socially, with speech and interactively as well as normal eating habits. After the MMR vaccine patient regressed in his development socially, interactively, eating habits and also in his speech. He now sees a Neuromuscular Specialist and has a developmental delay as well as a speech delay. Once we realized that patient has developed these delays his pediatrician referred patient to begin speech therapy. It took a few months to begin this process. Patient's speech therapist is strongly recommending Occupational Therapy for patient's other developmental delay. However, the state strongly discourages more than one therapy given and only prefers that one therapy per week. Speech Therapy is a funded program through the state, however because patient does not have insurance, therefore we have to pay a percentage of each speech therapy visit. We cannot afford private Occupational Therapy treatment at this time. Mother (myself) has also found the Protocol and began that in January to help heal the brain/gut injury due to the MMR vaccine. As time went on from May 11, 2017 and watching patient slip away to this mental fog and regress in his already met milestones has been one of the scariest things I've ever seen as a parent. Watching videos recorded and picture taken of patient prior to the MMR vaccine and seeing his normal behavior and eye contact and interactions and love for various foods back then eat breaks a mother's heart.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Speech disorder developmental, Stereotypy, Thyroxine free
Clinical narrative: After receiving the MMR Vaccine on May 11, 2017, patient slowly slipped away into what seemed to be a mind fog. He stopped giving eye contact and developed a severe complex motor stereotypy. Prior to May 11, 2017, patient met all his milestones, socially, with speech and interactively as well as normal eating habits. After the MMR vaccine patient regressed in his development socially, interactively, eating habits and also in his speech. He now sees a Neuromuscular Specialist and has a developmental delay as well as a speech delay. Once we realized that patient has developed these delays his pediatrician referred patient to begin speech therapy. It took a few months to begin this process. Patient's speech therapist is strongly recommending Occupational Therapy for patient's other developmental delay. However, the state strongly discourages more than one therapy given and only prefers that one therapy per week. Speech Therapy is a funded program through the state, however because patient does not have insurance, therefore we have to pay a percentage of each speech therapy visit. We cannot afford private Occupational Therapy treatment at this time. Mother (myself) has also found the Protocol and began that in January to help heal the brain/gut injury due to the MMR vaccine. As time went on from May 11, 2017 and watching patient slip away to this mental fog and regress in his already met milestones has been one of the scariest things I've ever seen as a parent. Watching videos recorded and picture taken of patient prior to the MMR vaccine and seeing his normal behavior and eye contact and interactions and love for various foods back then eat breaks a mother's heart.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient has painful burning sensation and red inflamed area that started slowly in muscle at injection site. Burning sensation, and red, inflamed area described as pain level 7 or 8/10, and has slowly moved from whole tricep down arm, and is currently affecting bicep area. No other area has been affected thus far.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Flatulence, Injection site pain, Limb discomfort, Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX. Previously administered products included TYLENOL. On 25th April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced pain in hand, nerve pain, flatulence and arm discomfort. On 25th April 2018, the patient experienced injection site pain. On 26th April 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the pain in hand, nerve pain, flatulence and arm discomfort were unknown. It was unknown if the reporter considered the injection site pain, pain in hand, nerve pain, flatulence and arm discomfort to be related to SHINGRIX. Additional information was reported as follows: The patient called to report adverse event experienced with SHINGRIX. On the night of vaccination, arm was very sore but it resolved by Thursday. The patient experienced discomfort in the under arm area, pain from arm to hands that felt nerve related, and also experiencing flatulence. The patient took TYLENOL WITH CODEINE from dentist 5 months ago to help him have a good night sleep. Follow up would be provided with the pharmacist.
Age: 0.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Dyskinesia, Fall, Loss of consciousness, Pain in extremity
Clinical narrative: Late entry 0953 11 year old female received Tdap and MCV-4 while getting in position to administer last shot (HPV-9) she had a syncope episode with Skin pale, clammy, jerking activity, unresponsive and sliding to the floor. Assisted patient to floor safely and elevated her feet. Patient regained consciousness immediately. Alert and oriented to name and place. BP 110/62 HR 88 respirations 22. No rashes noted, denied itching, no SOB Complained of nausea and headache. Lungs clear all 4 lobes. Patient hands shaking. After monitoring for 10 minutes on the floor with feet elevated, skin pink, alert and oriented to name place and year. Patient denies SOB, dizziness and stomach ache. Assisted patient to chair slowly and she tolerated well. HPV was given and patient tolerated well while laying down. Monitored patient for 15 more minutes and she was discharged home to follow-up with PCP. Mother was really nervous about family members with epilepsy and thought her daughter had a seizure. Explained syncope to mother and referred her to PCP for seizure/Epilepsy concerns. 1030 Patient sent home with mother ambulating with only complaints of pain in her arm. Vitals BP 108/62, Pulse 80, respirations 16. Mother verbalize good understanding of her follow-up instructions. On outreach unable to print AVS.
Age: 0.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pallor, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Late entry 0953 11 year old female received Tdap and MCV-4 while getting in position to administer last shot (HPV-9) she had a syncope episode with Skin pale, clammy, jerking activity, unresponsive and sliding to the floor. Assisted patient to floor safely and elevated her feet. Patient regained consciousness immediately. Alert and oriented to name and place. BP 110/62 HR 88 respirations 22. No rashes noted, denied itching, no SOB Complained of nausea and headache. Lungs clear all 4 lobes. Patient hands shaking. After monitoring for 10 minutes on the floor with feet elevated, skin pink, alert and oriented to name place and year. Patient denies SOB, dizziness and stomach ache. Assisted patient to chair slowly and she tolerated well. HPV was given and patient tolerated well while laying down. Monitored patient for 15 more minutes and she was discharged home to follow-up with PCP. Mother was really nervous about family members with epilepsy and thought her daughter had a seizure. Explained syncope to mother and referred her to PCP for seizure/Epilepsy concerns. 1030 Patient sent home with mother ambulating with only complaints of pain in her arm. Vitals BP 108/62, Pulse 80, respirations 16. Mother verbalize good understanding of her follow-up instructions. On outreach unable to print AVS.
Sex: M
Vaccine: FLUX
Symptoms: Negative thoughts, Suicidal ideation
Clinical narrative: This serious spontaneous case initially received from other non-health professional (consumer) on 27-Apr-2018, concerning a 55-year-old, adult, male patient. The patient's current condition included sensitivity to dyes, chemicals and was on very strict plant based diet due to it. The patient had no other medical issues and concomitant medications. On an unspecified date in 2012 (reported in 2017 as 5 years ago), the patient was administered with INN (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed thoughts of hopelessness which turned into suicidal thoughts. It took 5 months for the patient to recover from the events- thoughts of hopelessness and suicidal thoughts.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Negative thoughts, Suicidal ideation
Clinical narrative: This serious spontaneous case, initially received from other non-health professional (consumer) on 27-Apr-2018, concerning a 60-year-old, adult, male patient. The patient received influenza vaccine (reported as 5 years ago), which lead to thoughts of hopelessness turned into suicidal thoughts and took 5 months to resolve. The patient had been sensitive to dyes, chemicals and was on very strict plant based diet due to it. The patient did not receive any concomitant medications. On 08-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On 08-Dec-2017, after 1 month 1 day of vaccination, the patient experienced thoughts of hopelessness which turned into suicidal thoughts. The reporter stated that, the suicidal thoughts were gradual. The patient received RISPERDAL (1/2-1mg per day) and had appointment with psychologist in 2 weeks. It was reported that, patient was feeling better with RISPERDAL but upon discontinuation, he again experienced the thoughts of hopelessness. At the time of this report, the patient had not yet recovered from the events. The reporter considered the causality of the event as related to the suspect vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: 2 hours after vaccines given left lower extremity from hip to Ankle was completely red; Right thigh was red. 30 min later entire Right lower extremity was red. 4 hours after vaccines given legs were normal except a few petechiae in lower legs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Redness, swelling, spread down entire arm, pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Pain, Tremor
Clinical narrative: 12 hours after injection, developed shaking, violent shivers and freezing cold. Could not get warm. Aching all over. Resolved next day. Some local tenderness at the shot.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Blood test, Computerised tomogram, Hypersensitivity, Injection site rash, Peripheral swelling
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, X-ray
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Asthma, Injection site pain, Lymph node pain, Neck pain, Pyrexia
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Decreased appetite, Headache, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site swelling, Nausea, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a consumer via other and described the occurrence of asthmatic attack in a female patient who received SHINGRIX. Co-suspect products included PNEUMOVAX 23. On 15th April 2018, the patient received SHINGRIX and PNEUMOVAX 23. In April 2018, less than a month after receiving SHINGRIX, the patient experienced asthmatic attack (serious criteria hospitalization), fever, injection site pain, neck pain, lymph node pain and rash. On an unknown date, the outcome of the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash were unknown. It was unknown if the reporter considered the asthmatic attack, fever, injection site pain, neck pain, lymph node pain and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced adverse reactions such as fever, painful injection site, pain in neck and lymph nodes under arms, a rash on her shoulder, and asthma attack. The patient was hospitalized for 5 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Hot flush, Pain in extremity, Visual impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 28th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, flushing, light headedness, feeling hot and visual disturbance. On an unknown date, the outcome of the injection site pain, flushing, light headedness, feeling hot and visual disturbance were unknown. The reporter considered the injection site pain, flushing, light headedness and feeling hot to be possibly related to SHINGRIX. It was unknown if the reporter considered the visual disturbance to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced feverish feeling and dizziness.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Flushing, Injection site pain, Visual impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 28th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, flushing, light headedness, feeling hot and visual disturbance. On an unknown date, the outcome of the injection site pain, flushing, light headedness, feeling hot and visual disturbance were unknown. The reporter considered the injection site pain, flushing, light headedness and feeling hot to be possibly related to SHINGRIX. It was unknown if the reporter considered the visual disturbance to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced feverish feeling and dizziness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 70-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 27th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site nodule and red blotches. On an unknown date, the outcome of the injection site induration and red blotches were not recovered/not resolved and the outcome of the injection site erythema and injection site nodule were unknown. The reporter considered the injection site induration, injection site erythema, injection site nodule and red blotches to be almost certainly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient received the 1st dose of SHINGRIX and experienced a hard, red blotch an inch away from injection site. On 29 April 2018, the patient noticed the symptoms. No additional information.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 70-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 27th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site nodule and red blotches. On an unknown date, the outcome of the injection site induration and red blotches were not recovered/not resolved and the outcome of the injection site erythema and injection site nodule were unknown. The reporter considered the injection site induration, injection site erythema, injection site nodule and red blotches to be almost certainly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient received the 1st dose of SHINGRIX and experienced a hard, red blotch an inch away from injection site. On 29 April 2018, the patient noticed the symptoms. No additional information.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 70-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 27th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site nodule and red blotches. On an unknown date, the outcome of the injection site induration and red blotches were not recovered/not resolved and the outcome of the injection site erythema and injection site nodule were unknown. The reporter considered the injection site induration, injection site erythema, injection site nodule and red blotches to be almost certainly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient received the 1st dose of SHINGRIX and experienced a hard, red blotch an inch away from injection site. On 29 April 2018, the patient noticed the symptoms. No additional information.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness in a male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included antihistamine. On 9th April 2018 16:20, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 3 days after receiving SHINGRIX, the patient experienced muscle weakness (serious criteria disability) and pain in arm (serious criteria disability). In April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the muscle weakness was not recovered/not resolved. The reporter considered the muscle weakness and pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The patient was receiving antihistamine as concomitant drug. The patient did receive weekly allergy shots and had for the past 2 to 3 years. Less than a week after receiving vaccination, the patient had pain in the arm where he received the injection for the first couple days. By the 3rd day the patient noticed he was having trouble holding things with that arm. On Friday, 27th April 2018, the patient was unable to hold his dinner plate with the arm where he received SHINGRIX. The patient saw his health care professional that day and was referred to a neurologist, but the earliest appointment was in 3 weeks. The patient did not think the problem was related to his allergy shots.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness in a male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included antihistamine. On 9th April 2018 16:20, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 3 days after receiving SHINGRIX, the patient experienced muscle weakness (serious criteria disability) and pain in arm (serious criteria disability). In April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the muscle weakness was not recovered/not resolved. The reporter considered the muscle weakness and pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The patient was receiving antihistamine as concomitant drug. The patient did receive weekly allergy shots and had for the past 2 to 3 years. Less than a week after receiving vaccination, the patient had pain in the arm where he received the injection for the first couple days. By the 3rd day the patient noticed he was having trouble holding things with that arm. On Friday, 27th April 2018, the patient was unable to hold his dinner plate with the arm where he received SHINGRIX. The patient saw his health care professional that day and was referred to a neurologist, but the earliest appointment was in 3 weeks. The patient did not think the problem was related to his allergy shots.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Rapid heartbeat resting (110 to 130), headache, nausea, severe muscle and joint pain, redness at injection site and HOT to the touch for 3 days, warm to the touch as of today. Feelings of impending doom.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: Rapid heartbeat resting (110 to 130), headache, nausea, severe muscle and joint pain, redness at injection site and HOT to the touch for 3 days, warm to the touch as of today. Feelings of impending doom.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Headache, Heart rate increased, Injection site erythema
Clinical narrative: Rapid heartbeat resting (110 to 130), headache, nausea, severe muscle and joint pain, redness at injection site and HOT to the touch for 3 days, warm to the touch as of today. Feelings of impending doom.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: Rapid heartbeat resting (110 to 130), headache, nausea, severe muscle and joint pain, redness at injection site and HOT to the touch for 3 days, warm to the touch as of today. Feelings of impending doom.
Age: 73.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema
Clinical narrative: I was given the SHINGRIX 50mcg inj (IM) SNG DSE VL10PK and the PREVNAR 13 inj, 0.5ml in the muscle as directed both in the left arm. Approximately 3:30 pm in the afternoon on 05/01/2018. Was told may have redness and soreness. Didn't notice any of that until the next day 05/02/2018 approximately 4:00pm. The redness got worse and beings I had a appointment with my doctor on 05/04/2018 10:30 AM. She said to watch it and if it spreads any more to call the office on Monday 05/07/2018. I did and was told to come in. Was seen. Was given meds. Ranitidine 150mg and Cephalexin 500mg.