chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory, Tinnitus
Clinical narrative: bilateral sensorineural hearing loss; Tinnitus; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 10-MAY-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered constant ringing in his ears along with hearing loss and was diagnosed with bilateral sensorineural hearing loss (deafness neurosensory) and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to the resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the pt's sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of deafness neurosensory and tinnitus. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered deafness neurosensory and tinnitus to be disabling events.  Upon internal review, deafness neurosensory was determined to be a medically significant event.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; One female patient was inadvertently administered VARIVAX and M-M-R II before discovery of data logger malfunction; This spontaneous report was received from a medical assistant concerning a 12 month old female patient. There was no information about patient's concurrent conditions, medical history or concomitant medications.  On 17-FEB-2020, the patient was inadvertently vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024364 with expiration date of 06-AUG-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) lot #S018254 with expiration date of 19-MAY-2021 (route of administration and anatomical location were not reported) for prophylaxis, which were stored from 14-FEB-2020 after closing, to 17-FEB-2020, for 42 hours and 50 minutes; during the day the data logger malfunctioned. The malfunction was discovered after vaccinating the patient. The vaccines were reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT) lot # S025291 with expiration date of 23-APR-2022. No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Postherpetic neuralgia; Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. In or around 11-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location or route of administration were not provided) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 13-MAY-2015 (reported as "2 days after vaccination"), the patient suffered a severe rash characterized by blistering along with pain, redness and swelling across the left breast and back. She was diagnosed with shingles and postherpetic neuralgia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The herpes zoster and postherpetic neuralgia were considered disabling events.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Postherpetic neuralgia; Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. In or around 11-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location or route of administration were not provided) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 13-MAY-2015 (reported as "2 days after vaccination"), the patient suffered a severe rash characterized by blistering along with pain, redness and swelling across the left breast and back. She was diagnosed with shingles and postherpetic neuralgia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The herpes zoster and postherpetic neuralgia were considered disabling events.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Rash
Clinical narrative: neuropathic symptom concerns; Shingles; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 29-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for routine health maintenance and for the intended purpose: the prevention of shingles (herpes zoster). On 17-DEC-2013, the pt presented to the doctor with a painful rash on his body. The pt returned to the doctor several more times, for help with neuropathic symptom concerns, reporting on several occasions that he felt the shingles again. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expense and other economic and non-economic damages. All damage proximately caused by the characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt.  The reporter considered the events to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional symptoms; Patient was administered one dose of improperly stored VARIVAX; Patient was administered one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-FEB-2020, the patient was vaccinated with one improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX), lot # S025612 expiring on 18-AUG-2021, for prophylaxis (dose, route and site of administration were not reported).    The administered dose of the vaccine experienced a temperature excursion of -14°C to -10°C for 2 hours and a temperature excursion of -9°C to -8°C for 6 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Coma, Mental disability, Physical disability
Clinical narrative: Patient is currently "physically and mentally disabled"and has mental and or physical "capacity of an eight year old".; Patient is currently "physically and mentally disabled"and has mental and or physical "capacity of an eight year old".; On unspecified date three months after administration patient "went into a coma".; This spontaneous report was received from a nurse via company representative referring to an adolescent female patient. The patient didn't have pertinent medical history. Information about drug reaction or allergy and concomitant medication was not provided.      On an unknown date (reported as when patient was 16 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccine dosage detail, route of administration, lot# and expiration date were unknown) for routine recommendation. The patient did not experience any symptoms when she received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date (reported as the patient was then 17 years old), the patient was administered her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   On an unknown date, three months after her second dose administration, the patient went into a coma. On an unknown date, the patient was physically and mentally disabled and had mental and or physical capacity of an eight years old. The patient sought medical attention and received unknown treatment for the events. Information about lab diagnostics or studies was unknown by the reporter. The outcome of coma was recovered on an unknown date. The outcome of physically and mentally disabled was not recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   The event of physically and mentally disabled was determined to be life-threatening by the reporter.   Upon internal review, the event of coma was determined to be medically significant.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing in his ears; This spontaneous report was received from a pharmacist referring to a 73 year old male patient with no drug reactions/allergies, "multiple unspecified" medical history conditions, and on multiple unspecified concomitant medications.      On 26-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S006778, expiring on 28-NOV-2020, via intramuscular route, for routine vaccination.  On the same day, the patient also received a dose of zoster RGE vaccine (mammalian)(SHINGRIX) for an unknown indication (dose, route and site of administration, lot number and expiration date were not reported).   On the same date of vaccination, the patient experienced ringing in his ears (tinnitus).  The patient sought medical attention by contacting the pharmacist.  No treatment was given for the event. Not any laboratory test was performed.  At the reporting time the patient had not recovered of tinnitus.  The reporter did not assess the causal relationship between suspect therapies and the event.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Influenza like illness, Injection site pain, Loss of consciousness, Platelet count increased
Clinical narrative: elevated platelets (thrombocytosis); passed out; felt hot; flu like symptoms; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 9th January 2020, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling hot, influenza-like symptoms and injection site pain. On 20th January 2020, the patient experienced thrombocytosis. On 11th January 2020, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. On an unknown date, the outcome of the passed out, feeling hot and thrombocytosis were recovered/resolved.   It was unknown if the reporter considered the passed out, feeling hot, influenza-like symptoms, injection site pain and thrombocytosis to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's wife. The patient received Shingrix vaccine in unknown arm. The patient experienced passed out, feeling hot, influenza-like symptoms and injection site pain. The patient's platelets were elevated. The patient's wife reported that her husband planned to continue follow up with his physician. The ermergency room  visit was required. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Thrombocytosis
Clinical narrative: elevated platelets (thrombocytosis); passed out; felt hot; flu like symptoms; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 9th January 2020, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling hot, influenza-like symptoms and injection site pain. On 20th January 2020, the patient experienced thrombocytosis. On 11th January 2020, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. On an unknown date, the outcome of the passed out, feeling hot and thrombocytosis were recovered/resolved.   It was unknown if the reporter considered the passed out, feeling hot, influenza-like symptoms, injection site pain and thrombocytosis to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's wife. The patient received Shingrix vaccine in unknown arm. The patient experienced passed out, feeling hot, influenza-like symptoms and injection site pain. The patient's platelets were elevated. The patient's wife reported that her husband planned to continue follow up with his physician. The ermergency room  visit was required. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: diagnosed with cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with cancer after receipt of her first dose of Shingrix. The follow up consent was granted.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pruritus, Nasopharyngitis
Clinical narrative: Area where the injection is, started to get red and itchy; The area where the injection is, started to get red and itchy; cold with chills; cold with chills; sore throat; she woke up this morning all sweaty; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 27Feb2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at an unknown dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. The patient previously got pneumonia vaccine three years ago with no complications, lisinopril and experienced severe adverse reaction. The patient was administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) prescribed by her cardiologist who recommended to get a dose this year and one more dose one year later. The patient reported that the area where the injection is, started to get red and itchy. She stated that she had been taking diphenhydramine (BENADRYL) for the itchiness and redness that started 12 days after she got the Prevnar13. These symptoms are now gone. She mentioned she is feeling now like she is going to get a cold with chills and sore throat. She also mentioned she woke up this morning all sweaty. She asked if pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) had similar components to lisinopril as she had a severe adverse reaction to lisinopril in the past. The outcome of the events 'area where the injection is, started to get red and itchy' was recovered, and of the remaining events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Pruritus
Clinical narrative: Area where the injection is, started to get red and itchy; The area where the injection is, started to get red and itchy; cold with chills; cold with chills; sore throat; she woke up this morning all sweaty; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 27Feb2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at an unknown dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. The patient previously got pneumonia vaccine three years ago with no complications, lisinopril and experienced severe adverse reaction. The patient was administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) prescribed by her cardiologist who recommended to get a dose this year and one more dose one year later. The patient reported that the area where the injection is, started to get red and itchy. She stated that she had been taking diphenhydramine (BENADRYL) for the itchiness and redness that started 12 days after she got the Prevnar13. These symptoms are now gone. She mentioned she is feeling now like she is going to get a cold with chills and sore throat. She also mentioned she woke up this morning all sweaty. She asked if pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) had similar components to lisinopril as she had a severe adverse reaction to lisinopril in the past. The outcome of the events 'area where the injection is, started to get red and itchy' was recovered, and of the remaining events was unknown.   Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Patient experienced redness and swelling; Patient experienced redness and swelling; This is a spontaneous report from contactable other health professional via Pfizer Sales Representative. A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot CD0412. Exp Jan2022), via an unspecified route of administration on 20Feb2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced redness and swelling on 21Feb2020 with outcome of recovered in Feb2020.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Shivering, headache, fatigue, nausea. Could not go to work today. No tx sought. Feeling better this evening.
Age: 57.0
Sex: U
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Reaction is localized to the injection site.  It is tender and hot to the touch. Redness and swollen area is a large welt: 18 hours after injection it measured = 3 inches by 1.25 inches and was elevated about 1/8th of an inch from surrounding skin.  41 hours after injection it is less raised but the red, swollen welt area has grown to 4 inches by 1.75 inches in area.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Swelling of eyelid
Clinical narrative: Patient developed swelling of lower than upper eyelid of right eye. about ten-15 minutes after vaccine. given Benadryl with minimal improvement
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Immediate post-injection reaction, Pain in extremity, X-ray limb abnormal
Clinical narrative: 12/16/2019. Shot administered at 11:06 am Are immediately started to ache.  Continues to get worse as the day went on.  Put heat/cold took Advil that evening.  Continues to ache. Called pharmacy a few days later, told me it was a high dose and what I was feeling common.  Went to Walk in Clinic 1/13/2020.  Prescribed  Methylprednisolone 4 MG.  Pain in my arm went completely away while on the steroid. Day after I finished there prescription the pain came back even worse
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: pt indicated 3 hours after receiving the shot her harm got sore and started to swell.  She indicated that in 2 day after her both arms were swelling and very painful and she ended up going to ER.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain radiating down the arm. Still hasn't subsided as of today. Patient stated that it became sore the day after receiving the shot. He took a steroid dose pack the week after getting the shot and it did not provide any relief.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Mass, Peripheral swelling, Rash
Clinical narrative: Rt foot had a walnut size lump on the big toe joint, toes were black, significant swelling on sole of foot. Smaller lumps began to appear, spread to left foot. Knot and redness at injection site. Went away with Benadryl , Zyrtec and Epsom salt bath. 2nd day, school called to say rash and swelling were on hands and face. Fingers were black. face was more swollen on rt side with rt eye almost swelled shut. Treated again with Benedryl and Zyrtec. 3rd day, slight swelling in face, hives on arms, hands and hips.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Skin discolouration, Swelling face, Swelling of eyelid, Urticaria
Clinical narrative: Rt foot had a walnut size lump on the big toe joint, toes were black, significant swelling on sole of foot. Smaller lumps began to appear, spread to left foot. Knot and redness at injection site. Went away with Benadryl , Zyrtec and Epsom salt bath. 2nd day, school called to say rash and swelling were on hands and face. Fingers were black. face was more swollen on rt side with rt eye almost swelled shut. Treated again with Benedryl and Zyrtec. 3rd day, slight swelling in face, hives on arms, hands and hips.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Heart rate decreased, Hot flush, Hyperhidrosis, Migraine
Clinical narrative: About 5 minutes of receiving the flu shot, pt started feeling faint, hot/cold flashes, low pulse, and sweating.  Was told to stay still and sit down and rest.  Found out he hadn't eaten or drank anything today except for apple cider vinegar.  He was given orange juice (drank whole 16oz) and water.   After using rest room shortly after, he remained in pharmacy waiting area for observance for 30 minutes.  He did mention he was starting to fell like he was having a migraine and took some excedrin.  He left with his partner stating he was feeling much better.  Called the patient at 1pm and said he was feeling better but still not 100%.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: STIFF AND SORE NECK FOR 2 DAYS AFTERWARDS.  PATIENT WAS ABLE TO TREAT IT WITH ALEVE AND IT FELT BETTER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Headache, Pain, Skin exfoliation
Clinical narrative: Joint pain, skin hurt, freezing, headache, body aches
Age: 98.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Oedema peripheral, Peripheral swelling, Swelling
Clinical narrative: Bilateral lower leg edema and swelling reported by the nursing home. Taken into the Clinic for evaluation. Past medical history: Hypertension, alzheimers dementia without behavioral disturbances, probable recurrent transient ischemic attack. Physical examination: Vital signs stable. 2+ to 3+ edema from her knees down bilaterally. Minimal redness. There are swelling and blisters bilaterally, left more than right. She is currently wearing tubipgrips.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Rash
Clinical narrative: Her arm was swollen and she had a rash on her arm that eventually spread to her chest. The rash has gone away but her arm is still swollen
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: PER PARENT - yesterday morning her right, upper arm started to hurt, itch and was reddened and very warm to touch. Patient complained that her arm felt stiff as well. We have been treating her arm with hydro-cortisone, an alcohol rub, and a warm compress and giving her ibuprofen for the pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain, Pruritus, Skin warm
Clinical narrative: Significant pain, swelling, lump and redness, hot to the touch, itching.  Grew to inches in size before being treated.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Significant pain, swelling, lump and redness, hot to the touch, itching.  Grew to inches in size before being treated.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain in extremity, Rash, Sinusitis
Clinical narrative: Pt had only mild arm soreness until she started Doxycycline for a sinus infection 5 days after immunization. In the evening after starting Doxycycline she started to develop rash, pain, and hot to the touch. Pt came to pharmacy on 2/28/20 to ask what was wrong with her arm; now having a large red area that was hot to the touch from the injection site down to a few inches above her elbow. I advised her to go see a doctor. She returned later in the day with a Rx for Cephalexin and told me that the dr said it was cellulitis likely caused by the doxycycline interacting with the prevnar 13. Talked with pt on 3/2/20 and she is feeling much better, the pain and redness has greatly reduced and is better every day.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Pt had only mild arm soreness until she started Doxycycline for a sinus infection 5 days after immunization. In the evening after starting Doxycycline she started to develop rash, pain, and hot to the touch. Pt came to pharmacy on 2/28/20 to ask what was wrong with her arm; now having a large red area that was hot to the touch from the injection site down to a few inches above her elbow. I advised her to go see a doctor. She returned later in the day with a Rx for Cephalexin and told me that the dr said it was cellulitis likely caused by the doxycycline interacting with the prevnar 13. Talked with pt on 3/2/20 and she is feeling much better, the pain and redness has greatly reduced and is better every day.
Sex: M
Vaccine: FLU3, HEPA, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Error discovered 02/19/2020. No symptoms reported to office.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose, Dizziness, Loss of consciousness, Vomiting
Clinical narrative: After patient received immunization, patient starting feeling dizzy. Patient vomited. Patient passed out. Contacted 911. Paramedics checked patient BP, O2, and blood glucose. Patient then reported history of passing out after receiving HPV vaccine. Patient returned to go to ER. Patient recovered from adverse event. Contacted patient rep to have patient driven home
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, and sweeling to the left arm Benadryl
Age: 52.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Magnetic resonance imaging, Mobility decreased, Pain, X-ray
Clinical narrative: Pt cannot move her arm. She has had pain since shots were given. She said both shots were in same arm. She has done Physical therapy and now requires surgery.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: after administration around inj. site it became read, itchy, and burning, gave Benadryl and hydrocortisone cream left arm Still red when left office
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient came in one week after vaccine with rash and fever.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash all over. No fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash started on 2/27/2020. Low grade fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Pyrexia
Clinical narrative: 6 in wheal and flare around injection site - right thigh with redness. Given BENADRYL and was seen in office on day 3 of it. It was red and tender to touch. Also developed fever day after injection of 102. In office on day 3 reviewing pictures taken by parent the area of vaccine had improved.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Electrocardiogram, Headache, Laboratory test, Nausea
Clinical narrative: (L) arm pain Following Admin -> restless night with poor sleep due to pain. Also had HA and nausea. The morning if 8/7/19 pt. awakened with pain, fever, chills & subsequently fainted while walking in her home. Taken to ED.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain, Pain in extremity, Poor quality sleep, Pyrexia, Restlessness
Clinical narrative: (L) arm pain Following Admin -> restless night with poor sleep due to pain. Also had HA and nausea. The morning if 8/7/19 pt. awakened with pain, fever, chills & subsequently fainted while walking in her home. Taken to ED.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: (L) arm pain Following Admin -> restless night with poor sleep due to pain. Also had HA and nausea. The morning if 8/7/19 pt. awakened with pain, fever, chills & subsequently fainted while walking in her home. Taken to ED.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Limb discomfort, Shoulder injury related to vaccine administration
Clinical narrative: Patient was seated, nurse was standing. Gave the shot towards the back side of the upper arm. Did not landmark first. Painful injection. Mom called office next day, was told HPV shot can cause prolonged pain, use ice and Tylenol. Pain persisted.    Patient?s initial complaints of pain, we attributed to the vaccination. But as time went on it didn?t make sense that she should still be having shoulder pain from a shot.  Nov 19, 2019 we took her to orthopedist who suspected rotator cuff injury. Functional MRI on Dec 2nd after physical therapy did not ease pain. MRI negative, pain could not be explained, yet it persisted.  Saw physiatrist Dec 10, 2019 . Fluid accumulation in bursa. SIRVA suspected since pain started day of injection and had not cleared yet. Several fluid removals and cortisone injections have been given.  Feb 3rd nerve block confirmed that pain is coming from nerve in shoulder. Physiatrist recommended ablation.  Patient has been in pain every day since the shot was given. Never a day less than 2-3/10 pain scale and about 2-3 days per week of pain over 7/10 pain scale.  We told her pediatrician about SIRVA, they had never heard of it. We asked them to do a report as we had been told it was mandated. Late January we received a copy of the report, but some of the details are incorrect.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Aspiration bursa, Bursal fluid accumulation, Injection site pain, Magnetic resonance imaging normal, Nerve block
Clinical narrative: Patient was seated, nurse was standing. Gave the shot towards the back side of the upper arm. Did not landmark first. Painful injection. Mom called office next day, was told HPV shot can cause prolonged pain, use ice and Tylenol. Pain persisted.    Patient?s initial complaints of pain, we attributed to the vaccination. But as time went on it didn?t make sense that she should still be having shoulder pain from a shot.  Nov 19, 2019 we took her to orthopedist who suspected rotator cuff injury. Functional MRI on Dec 2nd after physical therapy did not ease pain. MRI negative, pain could not be explained, yet it persisted.  Saw physiatrist Dec 10, 2019 . Fluid accumulation in bursa. SIRVA suspected since pain started day of injection and had not cleared yet. Several fluid removals and cortisone injections have been given.  Feb 3rd nerve block confirmed that pain is coming from nerve in shoulder. Physiatrist recommended ablation.  Patient has been in pain every day since the shot was given. Never a day less than 2-3/10 pain scale and about 2-3 days per week of pain over 7/10 pain scale.  We told her pediatrician about SIRVA, they had never heard of it. We asked them to do a report as we had been told it was mandated. Late January we received a copy of the report, but some of the details are incorrect.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Neuralgia, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Patient was seated, nurse was standing. Gave the shot towards the back side of the upper arm. Did not landmark first. Painful injection. Mom called office next day, was told HPV shot can cause prolonged pain, use ice and Tylenol. Pain persisted.    Patient?s initial complaints of pain, we attributed to the vaccination. But as time went on it didn?t make sense that she should still be having shoulder pain from a shot.  Nov 19, 2019 we took her to orthopedist who suspected rotator cuff injury. Functional MRI on Dec 2nd after physical therapy did not ease pain. MRI negative, pain could not be explained, yet it persisted.  Saw physiatrist Dec 10, 2019 . Fluid accumulation in bursa. SIRVA suspected since pain started day of injection and had not cleared yet. Several fluid removals and cortisone injections have been given.  Feb 3rd nerve block confirmed that pain is coming from nerve in shoulder. Physiatrist recommended ablation.  Patient has been in pain every day since the shot was given. Never a day less than 2-3/10 pain scale and about 2-3 days per week of pain over 7/10 pain scale.  We told her pediatrician about SIRVA, they had never heard of it. We asked them to do a report as we had been told it was mandated. Late January we received a copy of the report, but some of the details are incorrect.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site discomfort, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Patient was seated, nurse was standing. Gave the shot towards the back side of the upper arm. Did not landmark first. Painful injection. Mom called office next day, was told HPV shot can cause prolonged pain, use ice and Tylenol. Pain persisted.    Patient?s initial complaints of pain, we attributed to the vaccination. But as time went on it didn?t make sense that she should still be having shoulder pain from a shot.  Nov 19, 2019 we took her to orthopedist who suspected rotator cuff injury. Functional MRI on Dec 2nd after physical therapy did not ease pain. MRI negative, pain could not be explained, yet it persisted.  Saw physiatrist Dec 10, 2019 . Fluid accumulation in bursa. SIRVA suspected since pain started day of injection and had not cleared yet. Several fluid removals and cortisone injections have been given.  Feb 3rd nerve block confirmed that pain is coming from nerve in shoulder. Physiatrist recommended ablation.  Patient has been in pain every day since the shot was given. Never a day less than 2-3/10 pain scale and about 2-3 days per week of pain over 7/10 pain scale.  We told her pediatrician about SIRVA, they had never heard of it. We asked them to do a report as we had been told it was mandated. Late January we received a copy of the report, but some of the details are incorrect.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Muscular weakness, Musculoskeletal pain
Clinical narrative: Shingrix vaccine. Initially I experienced these side effects as listed on the label: pain (78.0%), redness (38.1%), and swelling (25.9%); and myalgia (44.7%), fatigue (44.5%), headache (37.7%) for the first week. I'm continuing to experience pain and myalgia/weakness in my right shoulder. These symptoms started right away and have continued to date which is 3 1/2 months since the vaccine was administered on 11/1/2019. I have been going to physical therapy with minimal positive results. I reported this to GSK at the site below on 2/16/2020 but only received a generic email from GSK on 2/18/2020. Months of pain and myalgia are not listed as a severe adverse event on the label and should be reported and addressed as a severe side effect.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Shingrix vaccine. Initially I experienced these side effects as listed on the label: pain (78.0%), redness (38.1%), and swelling (25.9%); and myalgia (44.7%), fatigue (44.5%), headache (37.7%) for the first week. I'm continuing to experience pain and myalgia/weakness in my right shoulder. These symptoms started right away and have continued to date which is 3 1/2 months since the vaccine was administered on 11/1/2019. I have been going to physical therapy with minimal positive results. I reported this to GSK at the site below on 2/16/2020 but only received a generic email from GSK on 2/18/2020. Months of pain and myalgia are not listed as a severe adverse event on the label and should be reported and addressed as a severe side effect.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Shingrix vaccine. Initially I experienced these side effects as listed on the label: pain (78.0%), redness (38.1%), and swelling (25.9%); and myalgia (44.7%), fatigue (44.5%), headache (37.7%) for the first week. I'm continuing to experience pain and myalgia/weakness in my right shoulder. These symptoms started right away and have continued to date which is 3 1/2 months since the vaccine was administered on 11/1/2019. I have been going to physical therapy with minimal positive results. I reported this to GSK at the site below on 2/16/2020 but only received a generic email from GSK on 2/18/2020. Months of pain and myalgia are not listed as a severe adverse event on the label and should be reported and addressed as a severe side effect.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Gait inability, Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: radiculoneuropathy; she started to experience "tingling in the right leg"/she started to experience "weakness of the right leg"/patient began to "start tripping and falling"/patient was diagnosed with "foot drop"; radiculoneuropathy; This spontaneous report was received from a consumer and his 68-year-old wife, who was also the patient. The patient had no pertinent medical history nor allergies. Concomitant therapies included rosuvastatin calcium (CRESTOR).  On an unknown day in August 2017, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered in the left arm, lot number N010106, with an expiration date on 15-NOV-2018, for prophylaxis (route of administration was not reported).  On an unknown day in 2017 (also reported as: "two weeks after administration"), the patient started to experience "tingling in the right leg", then, four months after that, she started to experience "weakness of the right leg", and afterward, she began "tripping and falling, thus, the patient was diagnosed with "foot drop" (peroneal nerve palsy). Approximately in January 2018, the patient started physical therapy and in approximately December 2018, she started to see a neurologist. The patient had immune globulin infusions (reported as "IVIG infusions)" starting in March 2019, to rule out "radiculoneuropathy" (radiculopathy/neuropathy peripheral). In May 2019, the patient was done a spinal tap (results not provided). In September 2019, the patient finished immune globulin infusions.  It was reported that all throughout 2019, magnetic resonance imaging (MRI) from brain to feet were performed (results not reported) and on unspecified dates, multiple blood works, and four electromyography (EMG) tests were done, showing fine results except for weakness in the right leg.   At reporting time (reported as "currently"), she had not recovered from the events as she still experienced "decreased limb mobility" and had still physical therapy. The causality assessment between the adverse events and the suspect therapy was not provided.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Electromyogram abnormal, Fall, Gait disturbance, Immunoglobulin therapy
Clinical narrative: radiculoneuropathy; she started to experience "tingling in the right leg"/she started to experience "weakness of the right leg"/patient began to "start tripping and falling"/patient was diagnosed with "foot drop"; radiculoneuropathy; This spontaneous report was received from a consumer and his 68-year-old wife, who was also the patient. The patient had no pertinent medical history nor allergies. Concomitant therapies included rosuvastatin calcium (CRESTOR).  On an unknown day in August 2017, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered in the left arm, lot number N010106, with an expiration date on 15-NOV-2018, for prophylaxis (route of administration was not reported).  On an unknown day in 2017 (also reported as: "two weeks after administration"), the patient started to experience "tingling in the right leg", then, four months after that, she started to experience "weakness of the right leg", and afterward, she began "tripping and falling, thus, the patient was diagnosed with "foot drop" (peroneal nerve palsy). Approximately in January 2018, the patient started physical therapy and in approximately December 2018, she started to see a neurologist. The patient had immune globulin infusions (reported as "IVIG infusions)" starting in March 2019, to rule out "radiculoneuropathy" (radiculopathy/neuropathy peripheral). In May 2019, the patient was done a spinal tap (results not provided). In September 2019, the patient finished immune globulin infusions.  It was reported that all throughout 2019, magnetic resonance imaging (MRI) from brain to feet were performed (results not reported) and on unspecified dates, multiple blood works, and four electromyography (EMG) tests were done, showing fine results except for weakness in the right leg.   At reporting time (reported as "currently"), she had not recovered from the events as she still experienced "decreased limb mobility" and had still physical therapy. The causality assessment between the adverse events and the suspect therapy was not provided.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Lumbar puncture, Magnetic resonance imaging whole body, Mobility decreased, Muscular weakness, Neuropathy peripheral
Clinical narrative: radiculoneuropathy; she started to experience "tingling in the right leg"/she started to experience "weakness of the right leg"/patient began to "start tripping and falling"/patient was diagnosed with "foot drop"; radiculoneuropathy; This spontaneous report was received from a consumer and his 68-year-old wife, who was also the patient. The patient had no pertinent medical history nor allergies. Concomitant therapies included rosuvastatin calcium (CRESTOR).  On an unknown day in August 2017, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered in the left arm, lot number N010106, with an expiration date on 15-NOV-2018, for prophylaxis (route of administration was not reported).  On an unknown day in 2017 (also reported as: "two weeks after administration"), the patient started to experience "tingling in the right leg", then, four months after that, she started to experience "weakness of the right leg", and afterward, she began "tripping and falling, thus, the patient was diagnosed with "foot drop" (peroneal nerve palsy). Approximately in January 2018, the patient started physical therapy and in approximately December 2018, she started to see a neurologist. The patient had immune globulin infusions (reported as "IVIG infusions)" starting in March 2019, to rule out "radiculoneuropathy" (radiculopathy/neuropathy peripheral). In May 2019, the patient was done a spinal tap (results not provided). In September 2019, the patient finished immune globulin infusions.  It was reported that all throughout 2019, magnetic resonance imaging (MRI) from brain to feet were performed (results not reported) and on unspecified dates, multiple blood works, and four electromyography (EMG) tests were done, showing fine results except for weakness in the right leg.   At reporting time (reported as "currently"), she had not recovered from the events as she still experienced "decreased limb mobility" and had still physical therapy. The causality assessment between the adverse events and the suspect therapy was not provided.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.