chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Pt C/O L arm hurting for 1 week and developing a "bump" under the skin at the site of injection for 1 month. Following the injection had difficulty raising her arm above shoulder height for several days. Pt didn't notify clinic. Shared information upon return for second GARDASIL 9 vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise, Myalgia
Clinical narrative: About 24 hours after the injection, I developed a headache, fever, chills, and general muscle aches, in addition to a very sore arm around the injection site. I was sick in bed for two days. No treatment was given or received.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 24 hours after the injection, I developed a headache, fever, chills, and general muscle aches, in addition to a very sore arm around the injection site. I was sick in bed for two days. No treatment was given or received.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Cold sweat, Nausea, Refusal of treatment by patient, Skin warm, Tinnitus
Clinical narrative: Patient experienced ringing in the ears, nausea, and hot and clammy skin. 911 was called and patient refused to be taken to the emergency department for treatment.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Headache, Injection site erythema, Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of myalgia in a 65-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concurrent medical conditions included hypothyroidism, iodine allergy, vitamin D deficiency, hyperlipidemia and pre-diabetes. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia, headache, chills, and injection site erythema. On an unknown date, the outcome of the myalgia, headache, chills and injection site erythema were recovering/resolving. The reporter considered the myalgia, headache and chills to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The case was not reported for a medical device. No cosmetic product was involved. Follow-up and targeted follow-up was not requested. The case was not associated with any product complaint. The patient received SHINGRIX vaccine on 14th May 2018. On 15th May 2018, late morning the patient experienced diffuse myalgia's and injection site redness associated with headaches. The chills presented, the patient was bedridden all the day afebrile. On 16th May 2018 the events improved mildly.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chemotherapy, Laboratory test abnormal, Lung cancer metastatic, Lung neoplasm surgery, Metastases to the mediastinum
Clinical narrative: This spontaneous report was received from an approximately 70 years old male nurse who was also the patient. The patient's concurrent condition included chronic obstructive pulmonary disease. The patient did not have concomitant medications or drug reactions/allergies. Approximately in 2008 (reported as 10 years ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. Approximately in 2014 (reported as 4 years ago), the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2016, the patient was operated on left upper lobe for non-small lung carcinoma. Then on an unspecified date, the patient was treated with cisplatin and another unspecified chemotherapy medication. On an unspecified date in 2017, a Positron Emission Tomography (PET) showed no active cancer and chemotherapy medications were terminated. On an unspecified date in 2018, the patient had tested and 90 % of expression for Programmed Death-ligand 1 (PD-L1) was found. On an unspecified date in March 2018, lesions in right lobe (lung cancer metastatic) were found with metastatic lesions in mediastinum and right clavicular. On 21-MAY-2018, the patient started therapy with KEYTRUDA (dose, frequency, lot # and expiration date were not reported) for routine vaccination. The patient did not seek medical attention. Additionally, the patient also reported that his spouse got influenza A, after getting an unspecified flu shot. No further information was provided. The outcome of non-small cell lung cancer and lung cancer metastatic was unknown. The reporter did not provide a causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the events non-small cell lung cancer and lung cancer metastatic were considered to be medically significant.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Non-small cell lung cancer, Positron emission tomogram normal
Clinical narrative: This spontaneous report was received from an approximately 70 years old male nurse who was also the patient. The patient's concurrent condition included chronic obstructive pulmonary disease. The patient did not have concomitant medications or drug reactions/allergies. Approximately in 2008 (reported as 10 years ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. Approximately in 2014 (reported as 4 years ago), the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2016, the patient was operated on left upper lobe for non-small lung carcinoma. Then on an unspecified date, the patient was treated with cisplatin and another unspecified chemotherapy medication. On an unspecified date in 2017, a Positron Emission Tomography (PET) showed no active cancer and chemotherapy medications were terminated. On an unspecified date in 2018, the patient had tested and 90 % of expression for Programmed Death-ligand 1 (PD-L1) was found. On an unspecified date in March 2018, lesions in right lobe (lung cancer metastatic) were found with metastatic lesions in mediastinum and right clavicular. On 21-MAY-2018, the patient started therapy with KEYTRUDA (dose, frequency, lot # and expiration date were not reported) for routine vaccination. The patient did not seek medical attention. Additionally, the patient also reported that his spouse got influenza A, after getting an unspecified flu shot. No further information was provided. The outcome of non-small cell lung cancer and lung cancer metastatic was unknown. The reporter did not provide a causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Upon internal review, the events non-small cell lung cancer and lung cancer metastatic were considered to be medically significant.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 74 year old female patient. The patient current condition included allergy to sulfas. None pertinent medical history nor concomitant medication was reported. On 16-MAY-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23, lot # N027624 and expiration date 11-MAY-2019, intramuscular for prophylaxis. (Dose was not reported). On 17-MAY-2018, the patient returned to the physician office with a "bad cellulitis of the left upper inner arm, not where the injection was received". The patient was given a one-time ROCEPHIN injection, dose not specified, and she was prescribed KEFLEX for ten days. None diagnostic laboratories were performed. At the reporting time, the current status of the patient was unknown. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the cellulitis. Upon internal review the cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA009622.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 6 month old child patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-MAY-2018, the patient was vaccinated with the first dose of ROTATEQ (lot # reported as N026174 with expiration date reported as 16-MAR-2019), per oral for prophylaxis. No adverse effects were reported. Lot number N026174 is an invalid lot number for ROTATEQ.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-AUG-2013 (conflicting information), the patient was inoculated with ZOSTAVAX at a physician office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-AUG-2013 (conflicting information), the patient was treated at a physician office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-DEC-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-JUL-2011, the patient was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe shingles. On or about 01-AUG-2011, the patient sought subsequent treatment at physician office for ongoing and worsening symptoms of herpes zoster and shingle outbreaks. The patient has been prescribed Lidoderm for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, they have one store with a patient who reported facial swelling within 24 hours after receiving SHINGRIX vaccine. The reporter wanted to know if there was any literature on facial swelling. This case was linked with US2018GSK089617, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt. arm/deltoid 13cm x 11cm red, raised area. Warm to the touch.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Approximately 5 minutes after receiving vaccinations, patient became pale and diaphoretic. Patient stated that she was lightheaded and could not breathe. Pulse was weak with a rate 76 bpm. Blood pressure was 90/58. Patient was sweating profusely. C/O nausea and feeling like she was going to faint. Patient given cool cloths and observed by nursing staff until episode subsided. Vitals signs taken. She was observed for approximately 30 minutes. Patient stated she felt "much better" before leaving the health department.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pulse abnormal
Clinical narrative: Approximately 5 minutes after receiving vaccinations, patient became pale and diaphoretic. Patient stated that she was lightheaded and could not breathe. Pulse was weak with a rate 76 bpm. Blood pressure was 90/58. Patient was sweating profusely. C/O nausea and feeling like she was going to faint. Patient given cool cloths and observed by nursing staff until episode subsided. Vitals signs taken. She was observed for approximately 30 minutes. Patient stated she felt "much better" before leaving the health department.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Pt presented in office a couple of weeks after injection of PROQUAD with a large bump and redness and irritation at the sight of the injection.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Confusional state, Epistaxis, Headache, Skull X-ray
Clinical narrative: Syncopal episode with epistaxis post vaccination and confusion to occipital region. Patient complains of blurry vision, headache and stomach ache after 10 minutes of vaccination. Ice pack was applied on head and provided with water. Follow up if symptoms worsen or as needed or post x-rays.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Vision blurred
Clinical narrative: Syncopal episode with epistaxis post vaccination and confusion to occipital region. Patient complains of blurry vision, headache and stomach ache after 10 minutes of vaccination. Ice pack was applied on head and provided with water. Follow up if symptoms worsen or as needed or post x-rays.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Left arm severe pain and redness with lump. States she was unable to move her arm for approx. 2 days. She states she had a large lump on her arm. She was seen by me 5/29/18 she states it is much better at this time. Still with grape size lump left deltoid and mild erythema circular area around injection site with tenderness. No drainage. Does not appear to be infected. She did not come to the office to be treated for this. I am seeing her for a follow up visit for a different reason, and she wanted me to know about this reaction so I may report it. She is improving, not resolved yet. She is moving her left arm without difficulty now.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complaint of pain to left arm and can not rise up to a certain height. No redness, swelling or warmness to touch noted on 5/21/18,5/25/18 or 5/29/2018.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Adenovirus test, Blood culture negative, C-reactive protein increased, Chlamydia test negative, Condition aggravated
Clinical narrative: Atypical Steven's Johnson Syndrome ~15 days post vaccination. Recurrence of SJS (as noted previously, ~3 months ago had SJS secondary to influenza B). Developed mouth + eye + penis involvement (ulcerations, clear discharge, pain, photosensitivity) starting 14 days post vaccination.  Worsening over the next two days. History of preceding URI as well about 10 days prior to SJS symptom appearance. Patient admitted to the hospital on 5/25/2018 (15 days post vaccination) -- started on acyclovir, IVFs, clindamycin (secondary to concern of bacterial superinfection of extensive mouth lesions), tobradex drops, and IV steroids (3 days; 1mg/kg/day of Solumedrol). Improving 4 days into hospitalization. Patient received ophtho consult, peds ID consult, and peds GI (to evaluate for esophageal involvement). Dermatology consulted via phone over the weekend. Etiology of recurrent SJS believed secondary to recent URI versus receipt of influenza vaccine --- contacting VAERS for review and recommendation for receipt of influenza vaccine next year. At this time, tracking down lot/manufacturer of influenza vaccine received as well as DTaP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Discharge, Enterovirus test negative, Herpes simplex test negative, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Atypical Steven's Johnson Syndrome ~15 days post vaccination. Recurrence of SJS (as noted previously, ~3 months ago had SJS secondary to influenza B). Developed mouth + eye + penis involvement (ulcerations, clear discharge, pain, photosensitivity) starting 14 days post vaccination.  Worsening over the next two days. History of preceding URI as well about 10 days prior to SJS symptom appearance. Patient admitted to the hospital on 5/25/2018 (15 days post vaccination) -- started on acyclovir, IVFs, clindamycin (secondary to concern of bacterial superinfection of extensive mouth lesions), tobradex drops, and IV steroids (3 days; 1mg/kg/day of Solumedrol). Improving 4 days into hospitalization. Patient received ophtho consult, peds ID consult, and peds GI (to evaluate for esophageal involvement). Dermatology consulted via phone over the weekend. Etiology of recurrent SJS believed secondary to recent URI versus receipt of influenza vaccine --- contacting VAERS for review and recommendation for receipt of influenza vaccine next year. At this time, tracking down lot/manufacturer of influenza vaccine received as well as DTaP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Influenza virus test negative, Mouth ulceration, Mucosal inflammation, Mycoplasma test negative, Pain
Clinical narrative: Atypical Steven's Johnson Syndrome ~15 days post vaccination. Recurrence of SJS (as noted previously, ~3 months ago had SJS secondary to influenza B). Developed mouth + eye + penis involvement (ulcerations, clear discharge, pain, photosensitivity) starting 14 days post vaccination.  Worsening over the next two days. History of preceding URI as well about 10 days prior to SJS symptom appearance. Patient admitted to the hospital on 5/25/2018 (15 days post vaccination) -- started on acyclovir, IVFs, clindamycin (secondary to concern of bacterial superinfection of extensive mouth lesions), tobradex drops, and IV steroids (3 days; 1mg/kg/day of Solumedrol). Improving 4 days into hospitalization. Patient received ophtho consult, peds ID consult, and peds GI (to evaluate for esophageal involvement). Dermatology consulted via phone over the weekend. Etiology of recurrent SJS believed secondary to recent URI versus receipt of influenza vaccine --- contacting VAERS for review and recommendation for receipt of influenza vaccine next year. At this time, tracking down lot/manufacturer of influenza vaccine received as well as DTaP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Photosensitivity reaction, Polymerase chain reaction, Respiratory syncytial virus test negative, Stevens-Johnson syndrome, Viral test negative
Clinical narrative: Atypical Steven's Johnson Syndrome ~15 days post vaccination. Recurrence of SJS (as noted previously, ~3 months ago had SJS secondary to influenza B). Developed mouth + eye + penis involvement (ulcerations, clear discharge, pain, photosensitivity) starting 14 days post vaccination.  Worsening over the next two days. History of preceding URI as well about 10 days prior to SJS symptom appearance. Patient admitted to the hospital on 5/25/2018 (15 days post vaccination) -- started on acyclovir, IVFs, clindamycin (secondary to concern of bacterial superinfection of extensive mouth lesions), tobradex drops, and IV steroids (3 days; 1mg/kg/day of Solumedrol). Improving 4 days into hospitalization. Patient received ophtho consult, peds ID consult, and peds GI (to evaluate for esophageal involvement). Dermatology consulted via phone over the weekend. Etiology of recurrent SJS believed secondary to recent URI versus receipt of influenza vaccine --- contacting VAERS for review and recommendation for receipt of influenza vaccine next year. At this time, tracking down lot/manufacturer of influenza vaccine received as well as DTaP.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site scar, Injection site swelling
Clinical narrative: Patient states her arm hurt immediately with burning at time of injection then immediate soreness afterwards. 3 days after immunization her arm was still sore and developed bruising, swelling, and heat at site of injection and traveled down her arm (about 2 1/2 inches from injection site). She states these symptoms existed for 2 weeks before resolving. She still has a scar on her arm from where injection was given.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient states her arm hurt immediately with burning at time of injection then immediate soreness afterwards. 3 days after immunization her arm was still sore and developed bruising, swelling, and heat at site of injection and traveled down her arm (about 2 1/2 inches from injection site). She states these symptoms existed for 2 weeks before resolving. She still has a scar on her arm from where injection was given.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient with large itchy uncomfortable welts on trunk, abdomen, back and left.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever to 102, headache, chills, myalgia.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Exposure during pregnancy
Clinical narrative: G4P1112 at 27w6d. Dx of cellulitis 2 days after receiving. Treated with cephalexin (KEFLEX) 500 MG capsule  Indications: Cellulitis of right upper extremity Take 1 Cap by mouth three times a day for 7 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Patient here post vaccines with reaction on the left deltoid. Family reports that immediately after the vaccines, he started to have some redness. Over the next couple of days, the area started to swell and become warm to the touch. Patient told mother that it was tender to touch, but then denied that it was painful today. No V/D/rash/fever. Appetite and sleep normal. No ill contacts. Family told to do warm/cold compress, start ibuprofen, take antihistamines, and to FU if any s/sx of infection occur.  On exam: Patient has lesion on left deltoid that has 1cmx.5cm area of erythema and induration, no exudate and no warmth to touch. Area does not appear infected.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Patient here post vaccines with reaction on the left deltoid. Family reports that immediately after the vaccines, he started to have some redness. Over the next couple of days, the area started to swell and become warm to the touch. Patient told mother that it was tender to touch, but then denied that it was painful today. No V/D/rash/fever. Appetite and sleep normal. No ill contacts. Family told to do warm/cold compress, start ibuprofen, take antihistamines, and to FU if any s/sx of infection occur.  On exam: Patient has lesion on left deltoid that has 1cmx.5cm area of erythema and induration, no exudate and no warmth to touch. Area does not appear infected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Nausea, Pain
Clinical narrative: Patient reported nausea, abdominal pain, headache, fever, chills, body ache. Severe side effects, specially body ache. When patient called she also reported feeling better than prior day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported nausea, abdominal pain, headache, fever, chills, body ache. Severe side effects, specially body ache. When patient called she also reported feeling better than prior day.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Arm was brusied near site of injections and swollen and red to touch. Redness spread throughout the inside of the arm all the way down to the elbow and around to the outside. Patient used ice and ibuprofen.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient called 05/29/18, a week after vaccine was administered, to report pain/soreness to her left deltoid, left shoulder and neck. The patient states normal soreness associated with a vaccine, but reports increased pain to shoulder on 05/24/18, 2 days post administration of vaccine. Patient reports increased pain 3-5 days post administration of vaccine to deltoid/shoulder and neck. Patient took ibuprofen for pain and was advised to see her primary care physician if pain increases/persists.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site mass, Injection site swelling
Clinical narrative: Pt began to experience fatigue, fever, headache, chills and nausea. At the site of injection it felt hot and swollen lump like a hive.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Pt began to experience fatigue, fever, headache, chills and nausea. At the site of injection it felt hot and swollen lump like a hive.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAY-2018, the patient was vaccinated with a dose of expired VAQTA per intramuscular route, lot # M022531, expiration date 23-FEB-2018, (strength and frequency not reported) for prophylaxis. No adverse effect was reported.
Age: 10.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Seizure like phenomena, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report has received from a registered nurse via a company representative, referring to a 10 year old male patient. The patient had no medical history, concurrent conditions, drug, allergy history or concomitant medications to be reported. On 16-MAY-2018, the patient was vaccinated with GARDASIL 9 lot # N017686 in the right deltoid for prophylaxis (strength, dose, frequency, and expiration date were not provided). It was reported that on the same date, the patient also received BOOSTRIX in the same arm. Approximately 20 minutes after the patient received vaccination (on 16-MAY-2018), the patient fainted, and experienced seizure like activity, described as tonic clonic movements. It was reported that the patient received unspecified fluids and his heart rate and breathing were monitored as treatment for the events. On the same date, within 20 minutes after the onset of the event, the patient recovered from the generalised tonic-clonic seizure. The causality assessment between both vaccines and the event was not provided. Upon internal review, the events seizure like phenomena and tonic clonic movements were determined to be medically significant.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Developed a generalized raised, red rash within 48 hrs after receiving the vaccine. (04/19/2018) Rash appeared like stages of chicken pox rash and very itchy. Several calls were made to the clinic regarding the rash, but it was felt that it was not d.t. the vaccine. However, when seen my Dr. on 05/02/2018, it was determined to be a reaction to the SHINGRIX vaccine. Prednisone was described for 6 days and rash subsided.  Aprox. 48 hrs after last dose of prednisone, the rash reappeared and a 10 day course of Prednisone was prescribed. At this time, one week after the last dose of Prednisone, there are still patchy, itchy areas that are still appearing or have not gone completely away.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm where vaccine was administered was red and hot to the touch via patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster without complication.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Contusion, Pain
Clinical narrative: Bruise, soreness, she is still sore and has a bruise after 10 days. She said the bruise was worse before and has improved.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: INJECTION FELT LIKE A DRILL AND HURT CONSIDERABLY. COULD NOT SLEEP ALL NIGHT, WITH CHILLS, A HEADACHE AND SLIGHT NAUSEA. THE FOLLOWING DAY LOST MY APPETITE COMPLETELY AND WAS EXTREMELY LETHARGIC. INJECTION SITE WAS SWOLLEN AND RED AND THE SIZE OF A LARGE BASEBALL. AFTER 4 DAYS STARTED ITCHING AND NOW AM 95% BETTER. THIS WAS THE 2ND IN THE SERIES OF SHOTS, FIRST ONE DONE JAN. 16, 2018, ARM HURT, BUT NO MAJOR ILL EFFECTS.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Lethargy, Nausea, Pain in extremity
Clinical narrative: INJECTION FELT LIKE A DRILL AND HURT CONSIDERABLY. COULD NOT SLEEP ALL NIGHT, WITH CHILLS, A HEADACHE AND SLIGHT NAUSEA. THE FOLLOWING DAY LOST MY APPETITE COMPLETELY AND WAS EXTREMELY LETHARGIC. INJECTION SITE WAS SWOLLEN AND RED AND THE SIZE OF A LARGE BASEBALL. AFTER 4 DAYS STARTED ITCHING AND NOW AM 95% BETTER. THIS WAS THE 2ND IN THE SERIES OF SHOTS, FIRST ONE DONE JAN. 16, 2018, ARM HURT, BUT NO MAJOR ILL EFFECTS.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: INJECTION FELT LIKE A DRILL AND HURT CONSIDERABLY. COULD NOT SLEEP ALL NIGHT, WITH CHILLS, A HEADACHE AND SLIGHT NAUSEA. THE FOLLOWING DAY LOST MY APPETITE COMPLETELY AND WAS EXTREMELY LETHARGIC. INJECTION SITE WAS SWOLLEN AND RED AND THE SIZE OF A LARGE BASEBALL. AFTER 4 DAYS STARTED ITCHING AND NOW AM 95% BETTER. THIS WAS THE 2ND IN THE SERIES OF SHOTS, FIRST ONE DONE JAN. 16, 2018, ARM HURT, BUT NO MAJOR ILL EFFECTS.
Age: 55.0
Sex: M
Vaccine: YF
Symptoms: Blood culture negative, CSF culture negative, CSF glucose increased, CSF protein increased, CSF test normal
Clinical narrative: 11 days after Yellow Fever vaccination (STAMARIL), the Patient had a new-onset generalized tonic/clonic seizure (occurred at work) followed by a second when he reached the hospital. Rapidly ceased when he received treatment. He was not ill prior to the vaccination - perhaps fatigue one day before seizure. He did not have fevers. He recovered quickly and fully and was discharged two days later in stable condition. No sequelae.
Age: 55.0
Sex: M
Vaccine: YF
Symptoms: CSF white blood cell count negative, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction
Clinical narrative: 11 days after Yellow Fever vaccination (STAMARIL), the Patient had a new-onset generalized tonic/clonic seizure (occurred at work) followed by a second when he reached the hospital. Rapidly ceased when he received treatment. He was not ill prior to the vaccination - perhaps fatigue one day before seizure. He did not have fevers. He recovered quickly and fully and was discharged two days later in stable condition. No sequelae.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient was non- symptomatic following 24 hrs post vaccine but then began to have swelling, large redness, tenderness and itchiness. Patient stated that the site was also warm to touch. Patient came back into Immunization clinic to report that the redness, swelling and tenderness has now traveled down her arm into her right Bicep. Patient denies and additional symptoms. Patient did state that around the same time she noticed the symptoms she was also experiencing symptoms of nausea, fatigue and diarrhea. Patient is currently not experiencing same symptoms aside the redness, swelling and tenderness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient was non- symptomatic following 24 hrs post vaccine but then began to have swelling, large redness, tenderness and itchiness. Patient stated that the site was also warm to touch. Patient came back into Immunization clinic to report that the redness, swelling and tenderness has now traveled down her arm into her right Bicep. Patient denies and additional symptoms. Patient did state that around the same time she noticed the symptoms she was also experiencing symptoms of nausea, fatigue and diarrhea. Patient is currently not experiencing same symptoms aside the redness, swelling and tenderness.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 10 days total of hives; treated with ZYRTEC and ZANTAC.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a red itchy rash starting on her torso on day 5 after vaccination. Rash was itchy and not blistering. It was over a holiday weekend and patient does not have a primary care physician. Patient called nurse line on Monday and was instructed to treat itching with oral BENADRYL and topical hydrocortisone which was providing some relief, but when I spoke with her Monday she complained of being too drowsy so I recommended changing to oral cetirizine and topical diphenhydramine. Patient reported later in the day that she was getting better relief from this regimen. By Tuesday PM rash had resolved on back and was now only on extremities. I spoke with GSK medical information line who said this was consistent with SHINGRIX ADR. They said while GSK did not have an official recommendation for if patient should receive 2nd dose in series, CDC guidelines recommend patients do unless they have a level 3 or higher reaction, and that a reaction to 1st dose does not necessarily mean they will react to 2nd.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient developed a red itchy rash starting on her torso on day 5 after vaccination. Rash was itchy and not blistering. It was over a holiday weekend and patient does not have a primary care physician. Patient called nurse line on Monday and was instructed to treat itching with oral BENADRYL and topical hydrocortisone which was providing some relief, but when I spoke with her Monday she complained of being too drowsy so I recommended changing to oral cetirizine and topical diphenhydramine. Patient reported later in the day that she was getting better relief from this regimen. By Tuesday PM rash had resolved on back and was now only on extremities. I spoke with GSK medical information line who said this was consistent with SHINGRIX ADR. They said while GSK did not have an official recommendation for if patient should receive 2nd dose in series, CDC guidelines recommend patients do unless they have a level 3 or higher reaction, and that a reaction to 1st dose does not necessarily mean they will react to 2nd.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash generalised
Clinical narrative: Patient got rash all over body after 3 to 5 days, rash looks like little bump, itch, pain (more at night).
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Syncope
Clinical narrative: PATIENT REPORTS FAINTING APPROXIMATELY 25 MINUTES AFTER THE INJECTION AND NOT FEELING WELL SINCE THE INJECTION. NO MEDICAL TREATMENT SOUGHT AT THE TIME AND PATIENT DID NOT REPORT THIS TO THE PHARMACY UNTIL TODAY (05/29/2018). HE WENT TO URGENT CARE TODAY BECAUSE HE DOESN'T FEEL WELL, POSSIBLY FOR AN UNRELATED ISSUE BASED ON MEDICATIONS PRESCRIBED, BUT HE SAYS IS NOT SURE WHY HE IS STILL NOT FEELING WELL. PATIENT SAYS HIS ARM WAS SORE FOR DAYS. THAT HAS RESOLVED.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmological examination normal
Clinical narrative: Developed full-blown Shingles two days after having the vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Injection site pain, Lacrimation increased, Malaise
Clinical narrative: Shaking, fever, watery eyes, sore arm, pain in arm, dizziness, sick, pain at site, sweating.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Shaking, fever, watery eyes, sore arm, pain in arm, dizziness, sick, pain at site, sweating.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient started having tingling effect in her mouth, lips, ear, nose, under the eyes and at sinuses after 20 minutes of the receiving the vaccine. she consulted PCP and they recommended to take BENADRYL, which helped with her numbness but after four days still she had numbness.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: PATIENT REPORTED TO PHARMACY THAT HE EXPERIENCED RASH ALL OVER THE BODY AND DOCTOR TOLD PATIENT TO TAKE OTC LORATADINE TO CONTROL THE SYMPTOMS. THE RASH WAS GONE AFTER TAKING LORATADINE ON SUNDAY.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash
Clinical narrative: Severe headache and redness/rash at the site. Both shots were given on the left arm with the PNEUMOVAX being 1 inch above the SHINGRIX.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus generalised
Clinical narrative: PATIENT SAID AFTER THEY WENT HOME THEY STARTED FEELING A ITCHING SENSATION OVER THE WHOLE BODY AND INJECTION SITE WAS SWOLLEN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Skin warm
Clinical narrative: Patient received the second dose of SHINGRIX series on 5/26/18. She called today (5/29/18) and reported that she felt nausea on the day of the vaccination and developed redness and warmth the next day. She said her right hand up to her elbow was red and warm; and the right side of her chest was red and warm. She denied any redness or swelling at or around the site of injection. She did not report any problems breathing, chest tightness, or abnormal heart rate.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Feeding disorder, Fluid intake reduced
Clinical narrative: Woke up at 5:00 a.m. and had chills, muscle aches, no fever, neck pain, headache, dizziness, weakness, couldn't eat or drink, walked to bathroom and so dizzy I almost fell down. Rose from bed again at 7:00 a.m. and needed assistance downstairs, extremely weak and entire body was achy. Asked for assistance to the nearby sofa and covered with a blanket, stayed on sofa until 5:00 p.m. Took two TYLENOL Extra Strength every 6 hours until bed time that evening. Finally able to eat at 6:00 pm but still very weak until next day.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Woke up at 5:00 a.m. and had chills, muscle aches, no fever, neck pain, headache, dizziness, weakness, couldn't eat or drink, walked to bathroom and so dizzy I almost fell down. Rose from bed again at 7:00 a.m. and needed assistance downstairs, extremely weak and entire body was achy. Asked for assistance to the nearby sofa and covered with a blanket, stayed on sofa until 5:00 p.m. Took two TYLENOL Extra Strength every 6 hours until bed time that evening. Finally able to eat at 6:00 pm but still very weak until next day.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dehydration, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Began feeling a little strange the following evening at about bed time. Woke up about 3:00 am with very, very bad headache. Next morning still had head ache, felt sick to the stomach. I was in bed all day somewhat dehydrated could not take even fruit juice which I threw up, had head ache all day and later in the day aches and pains in the body. All had lessened by that evening when I could take some food, felt more or less normal the next morning.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Began feeling a little strange the following evening at about bed time. Woke up about 3:00 am with very, very bad headache. Next morning still had head ache, felt sick to the stomach. I was in bed all day somewhat dehydrated could not take even fruit juice which I threw up, had head ache all day and later in the day aches and pains in the body. All had lessened by that evening when I could take some food, felt more or less normal the next morning.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Cataract, Cataract operation, Central nervous system lesion, Eye inflammation
Clinical narrative: My daughter was given one dose of the GARDASIL vaccine shortly after it was released. She was sick for 4 days after getting that vaccine and could barely move. This was the only time she'd ever been seriously ill up until recently. Last year, 2017, during what should have been a normal yearly eye exam, her eye doctor discovered she had developed cataracts in both of her eyes. This had developed in the course of just over one year time. After getting cataract surgery on one of her eyes, it became evident there was other issues going on because her eyes showed ongoing inflammation, long term inflammation. After seeing a retina specialist, my daughter was diagnosed with Uveitis. We were told that this is caused by underlying issues or illnesses, but at this time, every test for a cause of the Uveitis has come back normal. We were then referred to a neurologist after lesions were found on her brain after a MRI. The neurologist advised us that the lesions were old, and were caused by either a head injury or past serious illness. My daughter has never had any head injuries, and the only time she was ever seriously ill was immediately after the GARDASIL vaccine. After reading up, I see that GARDASIL has been linked to causing Uveitis and stomach issues as well as inflammation. I asked the neurologist if the lesions and Uveitis could be caused by the vaccine she had yrs ago still affecting her, and he said that it was possible the lesions and Uveitis are a result of the vaccine, and how ill she was after getting it. I believe the only reason these side effects took so long to manifest is because she only received one dose of the vaccine, I believe the damage was done at that time, and now it's further effecting her health and life.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Gastric disorder, Immediate post-injection reaction, Laboratory test normal, Lethargy, Malaise
Clinical narrative: My daughter was given one dose of the GARDASIL vaccine shortly after it was released. She was sick for 4 days after getting that vaccine and could barely move. This was the only time she'd ever been seriously ill up until recently. Last year, 2017, during what should have been a normal yearly eye exam, her eye doctor discovered she had developed cataracts in both of her eyes. This had developed in the course of just over one year time. After getting cataract surgery on one of her eyes, it became evident there was other issues going on because her eyes showed ongoing inflammation, long term inflammation. After seeing a retina specialist, my daughter was diagnosed with Uveitis. We were told that this is caused by underlying issues or illnesses, but at this time, every test for a cause of the Uveitis has come back normal. We were then referred to a neurologist after lesions were found on her brain after a MRI. The neurologist advised us that the lesions were old, and were caused by either a head injury or past serious illness. My daughter has never had any head injuries, and the only time she was ever seriously ill was immediately after the GARDASIL vaccine. After reading up, I see that GARDASIL has been linked to causing Uveitis and stomach issues as well as inflammation. I asked the neurologist if the lesions and Uveitis could be caused by the vaccine she had yrs ago still affecting her, and he said that it was possible the lesions and Uveitis are a result of the vaccine, and how ill she was after getting it. I believe the only reason these side effects took so long to manifest is because she only received one dose of the vaccine, I believe the damage was done at that time, and now it's further effecting her health and life.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Neuro-ophthalmological test normal, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Quality of life decreased, Uveitis
Clinical narrative: My daughter was given one dose of the GARDASIL vaccine shortly after it was released. She was sick for 4 days after getting that vaccine and could barely move. This was the only time she'd ever been seriously ill up until recently. Last year, 2017, during what should have been a normal yearly eye exam, her eye doctor discovered she had developed cataracts in both of her eyes. This had developed in the course of just over one year time. After getting cataract surgery on one of her eyes, it became evident there was other issues going on because her eyes showed ongoing inflammation, long term inflammation. After seeing a retina specialist, my daughter was diagnosed with Uveitis. We were told that this is caused by underlying issues or illnesses, but at this time, every test for a cause of the Uveitis has come back normal. We were then referred to a neurologist after lesions were found on her brain after a MRI. The neurologist advised us that the lesions were old, and were caused by either a head injury or past serious illness. My daughter has never had any head injuries, and the only time she was ever seriously ill was immediately after the GARDASIL vaccine. After reading up, I see that GARDASIL has been linked to causing Uveitis and stomach issues as well as inflammation. I asked the neurologist if the lesions and Uveitis could be caused by the vaccine she had yrs ago still affecting her, and he said that it was possible the lesions and Uveitis are a result of the vaccine, and how ill she was after getting it. I believe the only reason these side effects took so long to manifest is because she only received one dose of the vaccine, I believe the damage was done at that time, and now it's further effecting her health and life.