chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, pain and warmth to site. Benadryl 12.5mg every 6 hours. First dose given in office.
Age: 65.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: PATIENT COMPLAINED OF REDNESS, RASH, SWELLING AND ITCHING SOON AFTER GETTING THE VACCINE. IT GOT WORSE THE NEXT DAY.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Mobility decreased, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: 1 week after the flu shot I woke up with mild to moderate left arm and neck pain. I thought I may have slept wrong on it. The pain has progressively gotten worse until now where I can hardly lift or use my arm. I have numbness and tingling from the top of my shoulder down to my middle two fingers. The pain keeps me awake at night and is making my life very difficult. I rate it at a 8/10 during the day and a 10/10 at night. Ibuprofen barely helps it, the heating pad provides very little relief as well. It has been 5 days since these symptoms began and are continuing to worsen. I will seek medical care by weeks end if this does not get better.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Staff gave the patient a flu shot. 15 minutes later, the patient and her mother told the pharmacist that they were having no interactions to the flu shot and that they were leaving the store. 5 minutes after that, the mother returned with the patient and said that the child was breaking out in hives and was having an allergic reaction to the flu shot. She requested some BENADRYL be given to the child. Staff noticed one small spot on the child's back. Staff gave the child 10 mls of BENADRYL liquid. Upon discussing the reaction further with the mother, it came to light that the child has had hives for the past 5 days. The mother said that the child gets allergy shots, but had to stop them because they couldn't make it to the clinic during school hours. She asked which antihistamine is best for hives, and staff told her ZYRTEC. Staff instructed her to continue to watch the hives and go straight to the ER if she noticed any swelling around the mouth or difficulty breathing. She said she would.
Age: 49.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient was hospitalized via ambulance due to adverse side effects. Swelling at site of injection mostly on left arm. Patient was stabilized and discharged on same day.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Patient came in Monday night (1/29/2018) stating that after the vaccine both her arms felt very weak. The right and left arms from her elbows down felt like the muscles were very weak and had a hard time moving them. She said she took TYLENOL this morning and they feel better now.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Type III immune complex mediated reaction, Vaccination site swelling
Clinical narrative: Arthus type reaction with redness and swelling in the upper arm surrounding the vaccination site. Pt. began noticing symptoms 1 day after vaccination. Reported she did not move are after symptoms occurred and only took Tylenol the night of 1/28/2018. No other treatment sought or completed.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Lip swelling, Pharyngeal oedema
Clinical narrative: Patient had swollen lips and throat at around 11am. Patient was treated with liquid Benadryl around 3pm and the swelling subsided. Patient was prescribed prednisone 20 mg tablets and an EpiPen.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: Experienced what felt like pain within normal limits for the first 48 hours after flu shot. On the 3rd day the pain was so bad I could not sleep. Pain was excruciating at times. Not able to shampoo hair, get dressed or move arm in any way without experiencing extreme pain. Decided to wait to see if there was any improvement over time. Pain has subsided some but I have very limited range of motion. I can only raise my arm chest high and not at all above my head. At times my shoulder will just start throbbing - without moving it at all. Brought this up to my physician on November 21 and physical therapy was prescribed. She was concerned that frozen shoulder would develop.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Experienced what felt like pain within normal limits for the first 48 hours after flu shot. On the 3rd day the pain was so bad I could not sleep. Pain was excruciating at times. Not able to shampoo hair, get dressed or move arm in any way without experiencing extreme pain. Decided to wait to see if there was any improvement over time. Pain has subsided some but I have very limited range of motion. I can only raise my arm chest high and not at all above my head. At times my shoulder will just start throbbing - without moving it at all. Brought this up to my physician on November 21 and physical therapy was prescribed. She was concerned that frozen shoulder would develop.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash macular, Urticaria
Clinical narrative: Pt reports that the reaction began on 1/25/18, and by 1/26/18, the injection site was "all welted up," hot, painful to touch, and felt like someone punched her really hard in the arm. When she came in to the pharmacy today on 1/29/18 to physically show me her arm, it still had some red blotches, she said it was still a little sore but for the most part was resolving on its own.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site urticaria, Irritability
Clinical narrative: Pt.'s mother reports pt. developing a hive type rash on the back of left leg during around 11:30 am on 1/28/2018, gave pt. 5mL of Benadryl. Then around 7:00 pm pt. was very irritable and had hives on bilateral legs and was covered from waist down. Mother gave 5mL of Benadryl and laid pt. down for bed. Pt. slept through the night with no problems, when pt.'s mother was checking on him this morning noticed red rash from waist down but had improved from the previous night. Pt.'s mother felt the rash was worse the previous evening because he wouldn't quit scratching at his legs. Child was given no additional doses of Benadryl and was at daycare today with no additional adverse event.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Pt.'s mother reports pt. developing a hive type rash on the back of left leg during around 11:30 am on 1/28/2018, gave pt. 5mL of Benadryl. Then around 7:00 pm pt. was very irritable and had hives on bilateral legs and was covered from waist down. Mother gave 5mL of Benadryl and laid pt. down for bed. Pt. slept through the night with no problems, when pt.'s mother was checking on him this morning noticed red rash from waist down but had improved from the previous night. Pt.'s mother felt the rash was worse the previous evening because he wouldn't quit scratching at his legs. Child was given no additional doses of Benadryl and was at daycare today with no additional adverse event.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Urticaria
Clinical narrative: Hives. BENADRYL was given in office and resolved hives.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Reaction localized at injection site. No systemic effects
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Husband called pharmacy at 7:30p on 1/29/18 and reported patient's arm still red where shot given.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cough, Nasal congestion, Pyrexia
Clinical narrative: Notified by Home Health Nurse 1/15/18 that patient had stuffy nose, low grade fever and slight cough post vaccine. Lungs clear.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Paraesthesia
Clinical narrative: Pt reports numbness upper (R) arm and tingling in (R) hand.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site nodule
Clinical narrative: Small nodule on (L) thigh.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Case number PHEH2016US029205, is an initial spontaneous report received from a nurse on 25 Oct 2016. This report refers to a 68 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza vaccine (manufacturer unknown, batch number: not reported) at an unknown dose intramuscularly on 17 Oct 2016. On the same day after vaccination, the patient experienced the pain in her arm that lasted for an unspecified amount of time. Nurse also reported that, the patient vomited after she got out of the shower on the same day after administration. The outcome of the events was reported as complete recovery on 17 Oct 2016. The seriousness of the events was reported as non serious. The causality of the events was not reported. Significant follow-up received on 12-Apr-2017: The VAERS ID was updated as 674380. The intermediary was filled as regulatory authority and the report sent to regulatory authority was checked as 'yes'. The reporter causality was changed to not reported and determined causality as related.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Bursitis, Injection site reaction
Clinical narrative: Patient came into Clinic on November 14, 2017 & reported that he has Bursitis in his left shoulder.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain
Clinical narrative: On Saturday, January 20, 2018 I noticed that my left arm was sore from the flu shot, but not at the injection site. My whole entire arm was sore from the shot. On Sunday morning, I was not able to lift my arm above my head. I would have a sharp shooting pain in my arm and my fingers would go numb. I was not able to change clothes on my own due to the pain being so intense. I cannot sleep on the left side of my body due to my arm hurting. After a week and a half of pain, I went to  Clinic on Monday, January 29th. I was prescribed a dose of 500mg Naproxen and a muscle relaxer to help me sleep. I am going back to see her again on Friday, February 2nd. She believes that due to the swelling in my arm, I have a rotator cuff injury. Depending on my pain on Friday, she may refer me to physical therapy.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Rotator cuff syndrome
Clinical narrative: On Saturday, January 20, 2018 I noticed that my left arm was sore from the flu shot, but not at the injection site. My whole entire arm was sore from the shot. On Sunday morning, I was not able to lift my arm above my head. I would have a sharp shooting pain in my arm and my fingers would go numb. I was not able to change clothes on my own due to the pain being so intense. I cannot sleep on the left side of my body due to my arm hurting. After a week and a half of pain, I went to  Clinic on Monday, January 29th. I was prescribed a dose of 500mg Naproxen and a muscle relaxer to help me sleep. I am going back to see her again on Friday, February 2nd. She believes that due to the swelling in my arm, I have a rotator cuff injury. Depending on my pain on Friday, she may refer me to physical therapy.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Throat irritation, Throat tightness
Clinical narrative: At about 6:30 patient began feeling a scratchy throat which slowly progressed to a tightening in her throat. She went to a walk in clinic and her blood pressure was quite elevated. BENADRYL was administered and symptoms subsided. When she presented at the pharmacy her concern was to identify any possible ingredients in the vaccine which might preclude any subsequent vaccinations with like ingredients.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On a unspecified date, the patient was vaccinated with a dose of improperly stored M-M-R II lot # M045401and expiration date of 14-NOV-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celcius degrees (10.7 Celcius degrees) for 50 minutes. No previous temperature excursion was reported.  No adverse effects were reported. No digital data logger was involved.
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Discomfort, Drug administered to patient of inappropriate age, Incorrect dose administered, Muscle fatigue
Clinical narrative: This spontaneous report as received from a 44 years old male patient referring himself. The patient had no medical history. The patient's concurrent condition included amoxicillin allergy (drug hypersensitivity). On an unknown date in June 2017 (reported as first week of June), the patient was vaccinated with first dose of GARDASIL 9 0.7 ml rather than 0.5 ml (Lot # and expiry date was not reported) for prophylaxis. Subsequently on an unknown date, the patient also received the second and third dose of GARDASIL 9 0.7 ml rather than 0.5 ml (Lot # and expiry date was not reported) for prophylaxis (overdose and drug administered to patient of inappropriate age). Concomitant therapies included emtricitabine, tenofovir disoproxil fumarate(TRUVADA) and cetirizine hydrochloride, pseudoephedrine hydrochloride(ZYRTEC-D). On an unknown date in 2017 (reported as after receiving the vaccine but it was not specified if that was after one or all doses), the patient experienced chills, muscle fatigue and felt like "he weight 4000 pounds" (discomfort). There was no treatment given for adverse event and there was no lab tests performed. The outcome of chills, discomfort and muscle fatigue was reported as recovered/resolved. There was no product quality complaint involved. The reporter did not provide the causality assessment for the events.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an office manager, referring to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JAN-2018 at a private doctor's office/hospital, the patient was vaccinated with an improperly stored dose of VAQTA lot # N019924, expiration date on 02-SEP-2018, dose 1, intramuscularly (anatomical location was not reported) for prophylaxis. No adverse events were reported. It was reported that the vaccine was purchased with private funds. The vaccine a temperature excursion of 47 Fahrenheit (F) to 77 F, during 35 minutes. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal distension, Arthralgia, Blood test, Chest X-ray, Dyspnoea
Clinical narrative: This spontaneous report as received from a registered nurse, via company representative, refers to a 21 year old non pregnant female patient of unknown age. The patient did not have any pertinent medical history or concomitant medications. The patient's concurrent conditions included shellfish allergy. On 06-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N021571, expiration date 29-APR-2020 (dose number and route of administration were not provided) for prophylaxis (reported as "routine vaccination"). In December 2017, after receiving GARDASIL 9, the patient experienced pain in her ribs (musculoskeletal chest pain), joint pain, fatigue and bloating. The patient sought medical attention by calling her physician on 14-DEC-2017. Moreover,  blood work, chest X-rays were performed, she also went to the cardiologist.  Additionally, the patient's mother called the reporting nurse to state that the patient was having insomnia, her feet and hands were numb (Hypoesthesia) and constantly sweating (Hyperhidrosis) and she was "easily winded" (Dyspnoea). The reporter considered that there was significant disability or incapacity as the patient was not able to go to school and leaving the house. The outcome of patient's pain in ribs, joint pain, fatigue and bloating was not reported. While the outcome of the patient's insomnia, feet and hands numbness, constantly sweating and dyspnoea was not recovered at the time of reporting. The reporting nurse did not relate the patient's adverse events to GARDASIL 9. The reporting nurse did not assess the causal relationship between the patient's adverse events to GARDASIL 9.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Hyperhidrosis, Hypoaesthesia, Insomnia, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report as received from a registered nurse, via company representative, refers to a 21 year old non pregnant female patient of unknown age. The patient did not have any pertinent medical history or concomitant medications. The patient's concurrent conditions included shellfish allergy. On 06-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N021571, expiration date 29-APR-2020 (dose number and route of administration were not provided) for prophylaxis (reported as "routine vaccination"). In December 2017, after receiving GARDASIL 9, the patient experienced pain in her ribs (musculoskeletal chest pain), joint pain, fatigue and bloating. The patient sought medical attention by calling her physician on 14-DEC-2017. Moreover,  blood work, chest X-rays were performed, she also went to the cardiologist.  Additionally, the patient's mother called the reporting nurse to state that the patient was having insomnia, her feet and hands were numb (Hypoesthesia) and constantly sweating (Hyperhidrosis) and she was "easily winded" (Dyspnoea). The reporter considered that there was significant disability or incapacity as the patient was not able to go to school and leaving the house. The outcome of patient's pain in ribs, joint pain, fatigue and bloating was not reported. While the outcome of the patient's insomnia, feet and hands numbness, constantly sweating and dyspnoea was not recovered at the time of reporting. The reporting nurse did not relate the patient's adverse events to GARDASIL 9. The reporting nurse did not assess the causal relationship between the patient's adverse events to GARDASIL 9.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal chest pain
Clinical narrative: This spontaneous report as received from a registered nurse, via company representative, refers to a 21 year old non pregnant female patient of unknown age. The patient did not have any pertinent medical history or concomitant medications. The patient's concurrent conditions included shellfish allergy. On 06-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N021571, expiration date 29-APR-2020 (dose number and route of administration were not provided) for prophylaxis (reported as "routine vaccination"). In December 2017, after receiving GARDASIL 9, the patient experienced pain in her ribs (musculoskeletal chest pain), joint pain, fatigue and bloating. The patient sought medical attention by calling her physician on 14-DEC-2017. Moreover,  blood work, chest X-rays were performed, she also went to the cardiologist.  Additionally, the patient's mother called the reporting nurse to state that the patient was having insomnia, her feet and hands were numb (Hypoesthesia) and constantly sweating (Hyperhidrosis) and she was "easily winded" (Dyspnoea). The reporter considered that there was significant disability or incapacity as the patient was not able to go to school and leaving the house. The outcome of patient's pain in ribs, joint pain, fatigue and bloating was not reported. While the outcome of the patient's insomnia, feet and hands numbness, constantly sweating and dyspnoea was not recovered at the time of reporting. The reporting nurse did not relate the patient's adverse events to GARDASIL 9. The reporting nurse did not assess the causal relationship between the patient's adverse events to GARDASIL 9.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-JAN-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot# reported as N027624 with expiration date of 05-NOV-2019, for prophylaxis (dose and route of administration were not reported). No symptoms reported. The administered dose of the vaccine experienced a temperature excursion of 70 F for 23 days. There were not previous temperature excursions and it was not a call because of a data logger. No product quality complaint was involved.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M020101, expiration date 07-MAR-2019 and ROTATEQ lot # N009948, expiration date 21-OCT-2018, for prophylaxis. The vaccines underwent a temperature excursion between 2°C to 8°C (8.4°C), during a time frame of 15 minutes, which was called by a data logger. Previous temperature excursions included 9°C to 25°C (10°C) for 4 hours and 15 minutes. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-DEC-2009, the patient was vaccinated at a hospital by a registered nurse with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2014, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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, Rash, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-AUG-2012, only a few days after being vaccinated, the patient was treated by a physician for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed prednisone, acyclovir, NEURONTIN, and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient received an improperly stored dose of GARDASIL 9, lot number: N020353 (expiration date: 28-APR-2020), for prophylaxis (strength, route and dosage schedule were not provided). There was digital data logger involved. The storage characteristics were the following: Temperature/Time frame:  below 32 F (30.9 F) for 6 hours 25 minutes Previous temperature excursion: 47 F to 77 F (50.7 F) for 1 hour 27 minutes No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 02-JUL-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and 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 14-JAN-2017, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly, lot # L019297 with expiration date of 18-AUG-2018, for prophylaxis. It was also reported that the patient's age did not match the age indicated for GARDASIL 9 administration. Additionally, a temperature excursion of 0.8 C for 24 hours and 30 minutes was reported prior to the vaccine administration. No previous temperature excursion and no adverse effects were reported. A digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-SEP-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-OCT-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Autism spectrum disorder, Cellulitis, Diarrhoea, Regressive behaviour
Clinical narrative: He got cellulitis, and severe diarrhea. He also started to regress and started showing signs of autism. His Dr is in agreement that all this was caused from his vaccines at 1 year of age.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient was given a Flu shot on 08/22/2017, called a day later stating her arm was hurting. She was advised that this is a normal occurrence and it should take a few days for the soreness to go away. She had a doctor's appointment with her Doctor a few months later around October 2017, and brought up the problem of her arm hurting but the doctor also told her to give it some more time for it to go away. Patient then visited pharmacy on 01/27/2018 around 4pm stating that it was still hurting and what to go from there. Pharmacist who administered the vaccination notified the doctor (faxed and left voicemails) to let them know and what the next course of action can be to help the patient on 01/29/2018.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Impaired work ability, Loss of personal independence in daily activities, Muscle atrophy, Muscular weakness
Clinical narrative: The morning following the vaccination I woke with burning pain in my shoulder region. Then became progressively worse over the next week. By the third day I was experiencing significant weakness in the involved extremity, which prevented me from working. Pain lasted 3-4 weeks. Frank muscle atrophy was apparent by week 4. Following evaluation by two neurologists I was diagnosed with brachial neuritis. This was confirmed by EMG. Treatment has included a course of steroids the first two weeks and Physical Therapy, which I continue to do daily. My ability to perform the tasks essential to my job (I am an Anesthesiologist) has been severely impaired. I have been doing very limited work on small/light patients since the acute pain phase resolved. My ability to perform daily activities is impaired. My ability to participate in my usual recreation activities remains severely impaired.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, Radiculitis brachial, Scan with contrast
Clinical narrative: The morning following the vaccination I woke with burning pain in my shoulder region. Then became progressively worse over the next week. By the third day I was experiencing significant weakness in the involved extremity, which prevented me from working. Pain lasted 3-4 weeks. Frank muscle atrophy was apparent by week 4. Following evaluation by two neurologists I was diagnosed with brachial neuritis. This was confirmed by EMG. Treatment has included a course of steroids the first two weeks and Physical Therapy, which I continue to do daily. My ability to perform the tasks essential to my job (I am an Anesthesiologist) has been severely impaired. I have been doing very limited work on small/light patients since the acute pain phase resolved. My ability to perform daily activities is impaired. My ability to participate in my usual recreation activities remains severely impaired.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: The morning following the vaccination I woke with burning pain in my shoulder region. Then became progressively worse over the next week. By the third day I was experiencing significant weakness in the involved extremity, which prevented me from working. Pain lasted 3-4 weeks. Frank muscle atrophy was apparent by week 4. Following evaluation by two neurologists I was diagnosed with brachial neuritis. This was confirmed by EMG. Treatment has included a course of steroids the first two weeks and Physical Therapy, which I continue to do daily. My ability to perform the tasks essential to my job (I am an Anesthesiologist) has been severely impaired. I have been doing very limited work on small/light patients since the acute pain phase resolved. My ability to perform daily activities is impaired. My ability to participate in my usual recreation activities remains severely impaired.
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Injection site joint pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Developed joint pain (left shoulder) one week after vaccination. Then similar symptoms in right shoulder; hands and fingers. No erythema or edema. No systemic symptoms. Symptoms have been resolving.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia, Sensory disturbance
Clinical narrative: Arm pain with bending and paresthesias in all fingers of right hand starting the day after vaccination. Patient saw provider 2 days after vaccination for exam of arm where decreased sensation was noted in the right arm. Recommended the patient take NSAIDs and ice for arm soreness related to vaccination and do shoulder shrugs and elbow range of motion exercises throughout the day.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Blood albumin, Blood glucose increased, Blood lactic acid normal, Crying, Electrocardiogram normal
Clinical narrative: Pt called the office crying stating that she has extreme pain in her right arm where she received the injections and she is unable to move her right arm. She also explained that it was red, swollen, and had red blotchy marks on it. She was advised to go to the ED where they obtained labs and EKG and did an assessment. They did not find any acute bony abnormality or acute abscess in the area.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Full blood count, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Pt called the office crying stating that she has extreme pain in her right arm where she received the injections and she is unable to move her right arm. She also explained that it was red, swollen, and had red blotchy marks on it. She was advised to go to the ED where they obtained labs and EKG and did an assessment. They did not find any acute bony abnormality or acute abscess in the area.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Injection site swelling, Lymphocyte count decreased, PCO2 normal, PO2 normal, Rash macular
Clinical narrative: Pt called the office crying stating that she has extreme pain in her right arm where she received the injections and she is unable to move her right arm. She also explained that it was red, swollen, and had red blotchy marks on it. She was advised to go to the ED where they obtained labs and EKG and did an assessment. They did not find any acute bony abnormality or acute abscess in the area.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Crying, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt called the office crying stating that she has extreme pain in her right arm where she received the injections and she is unable to move her right arm. She also explained that it was red, swollen, and had red blotchy marks on it. She was advised to go to the ED where they obtained labs and EKG and did an assessment. They did not find any acute bony abnormality or acute abscess in the area.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: Pt called the office crying stating that she has extreme pain in her right arm where she received the injections and she is unable to move her right arm. She also explained that it was red, swollen, and had red blotchy marks on it. She was advised to go to the ED where they obtained labs and EKG and did an assessment. They did not find any acute bony abnormality or acute abscess in the area.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Red raised bump at injection site with some yellowing. Oral BENADRYL and ibuprofen if painful. Have the patient monitor it, if it worsens seek medical help.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a nurse regarding a pregnant female patient of unknown age. Pertinent medical history and concomitant medication was not reported. Patient had no drug reactions/allergies. On 11-JAN-2018, patient received the first dose of GARDASIL 9 intramuscularly for prophylaxis. On the same day, the patient underwent pregnancy test. On 12-JAN-2018, the pregnancy test results received which was positive. The nurse was unsure of the pregnancy gestation. No adverse effect was reported.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: CSF culture positive, Haemophilus test positive, Meningitis haemophilus
Clinical narrative: Initial report received on 24 February 2014 from a healthcare provider via another manufacturer. A 5 month old patient, date of birth and sex not reported was immunized with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) and HAEMOPHILUS TYPE B (HIB) VACCINE, manufacturer unknown on an unreported date. Within a few months, date not reported, the patient experienced haemophilus influenza type b meningitis and possible vaccination failure. The patient has a history of being a twin born prematurely at 29 weeks gestation with intraventricular hemorrhage. The patient also has a history of gastroesophageal reflux disease. The patient received a 1st dose of PENTACEL and 2nd dose of Hib vaccine, (dates, route and site of administration) not reported. Concomitant medications include Zantac, dose and route not reported. Within a few months of vaccination in 2013, date not reported, the patient experienced haemophilus influenza type b meningitis and possible vaccination failure. Relevant test results included a CSF culture that was HIB positive by latex agglutination and haemophilus test positive in 2013. The patient was hospitalized, dates not reported. The patient outcome was not recovered (events were improved). No further details were available at the time of this report. Documents held by sender: None Addendum on 29 Jan 2018: Upon second medical examination of case at time of internal review the following has been modified in this case: Suspect product code changed to HAEMOPHILUS TYPE B (HIB) VACCINE from HAEMOPHILUS INFLUENZAE. Sender's Comments: PENTACEL as any vaccine, may not protect 100% of vaccinated individuals. In the reported case, the child likely received only one dose of PENTACEL and one dose of HIB, manufacturer unknown. It does not appear that the child was fully immunized at the time of the event. Additional information such as the full vaccination history, medical history, laboratory results confirming the diagnosis of Hib infection is needed to further assess the case.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling, redness, warmth, and pain.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Induration, Pain, Skin warm
Clinical narrative: Headache lasted 5 hrs. Large (5" x 3 1/2") hard area, hot, red and very painful to the touch. This has started to lessen but is still warm, red and sore on day 7.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Headache lasted 5 hrs. Large (5" x 3 1/2") hard area, hot, red and very painful to the touch. This has started to lessen but is still warm, red and sore on day 7.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: PT STATES LAST NIGHT SHE COULD NOT HOLD HER LEFT ARM UP. AFTER EXAMINING PT'S ARM SHE CAN MOVE WITH FULL RANGE OF MOTION WITHOUT HAVING PAIN. SAYS WHEN IT'S MOVED IT'S PAINFUL.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Agitation, Decreased appetite, Screaming, Viral infection
Clinical narrative: After receiving the first and second vaccine in this series, the patient experienced behavior that was out of the ordinary to include agitation, loss of appetite, and waking up screaming. After the first vaccination in the series these effects lasted for approximately one month. The patient had a visit with the pediatrician within a few weeks of the first vaccination and effects were thought to be related to a viral illness.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood pressure increased, Blood test normal, Condition aggravated, Heart rate increased, Tremor
Clinical narrative: Patient 4 hours after vaccines, pt became shaky and felt heart beating rapidly, went to urgent care and blood pressure 250/100 something (doesn't remember bottom number) and Drs couldn't find any reason that it was high, it came down on its own after about an hour without any treatment. No cause was found.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Frontal thinning noticed sometime in 10/2017. Alopecia Aerata noticed on 1/15/2018, started on corticosteroid injections to scalp on 1/19/2018, and Rogaine, not yet recovered.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Joint range of motion measurement, Laboratory test abnormal, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Within 5 minutes of receiving injection, range of motion was limited to movement no greater than 6" away from the body in all directions. No strength in the left arm. No improvement in symptoms for 7 days. Couldn't sleep on left side, virtually zero functionality of the left arm. Treatment sought at same  clinic at the same day clinic - initial treatment was toradol injection (at day ~4 following vaccine), and it didn't work. Went back at day 7 (post-vaccine), and received an anesthetic and then steroid shot in the shoulder joint. Apparent improvement following introduction of steroids directly into the shoulder joint.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Sensory disturbance, Sleep disorder
Clinical narrative: Within 5 minutes of receiving injection, range of motion was limited to movement no greater than 6" away from the body in all directions. No strength in the left arm. No improvement in symptoms for 7 days. Couldn't sleep on left side, virtually zero functionality of the left arm. Treatment sought at same  clinic at the same day clinic - initial treatment was toradol injection (at day ~4 following vaccine), and it didn't work. Went back at day 7 (post-vaccine), and received an anesthetic and then steroid shot in the shoulder joint. Apparent improvement following introduction of steroids directly into the shoulder joint.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Confusional state, Deep vein thrombosis, Disability
Clinical narrative: Swelling of entire left side from underarm down to feet immediately after injection swelling started for a week. Received Cephalexin 500 MG CAPSULES to counteract effects. Weak from 10/30/2017 to present. Confusion that required hospitalization on 12/25/2017 with more testing. Threw a clot and ended up with DVT along with bilateral pulmonary emboli for which disability continues to present.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Imaging procedure, Immediate post-injection reaction, Pulmonary embolism, Swelling, Thrombosis
Clinical narrative: Swelling of entire left side from underarm down to feet immediately after injection swelling started for a week. Received Cephalexin 500 MG CAPSULES to counteract effects. Weak from 10/30/2017 to present. Confusion that required hospitalization on 12/25/2017 with more testing. Threw a clot and ended up with DVT along with bilateral pulmonary emboli for which disability continues to present.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Feeling cold, Hyperhidrosis
Clinical narrative: Patient started to get dizzy, lightheaded and was sweating. Patient became cold and teeth were chattering.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: Left arm became swollen and red after shot (PNEUMOVAX) over a few hours. Pt took ibuprofen for issue overnight. Between report at 9:30 1/17/18 and noon 1/17/18 - swelling down, no headache/pain just discomfort. Pt says no further intervention is needed after suggestions to seek further treatment.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, General physical health deterioration, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 71-year-old male patient who received SHINGRIX. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 19th January 2018, the patient experienced chills, influenza like illness, general physical health deterioration and arthralgia. In January 2018, the outcome of the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain were recovered/resolved. The reporter considered the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to manufacturer. This case was reported by the physician who himself was the patient. The patient experienced severe pain and tenderness at the injection site (right deltoid) which started the evening after the vaccination. The next day, the patient began to experience shaking chills, severe arthralgia, and stated that he felt extremely fluish, like he wanted to die and was totally laid up. The reporter gave permission to be contacted regarding his experience. He was unable to provide the lot number and expiration date for the product administered.