chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: Chicken pox like spots/spots broke out on his back/; Joint pain; rash has now turned into bumps/red rash with little bumps; red rash; Rash on back/ shoulder/chest/forehead/face/around eyes/nose; itching on back/shoulder/chest/forehead/face/hair was itching/overall itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On 20th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2019, 7 days after receiving Shingrix, the patient experienced pruritus. On 4th December 2019, the patient experienced rash, varicella-like rash, joint pain, papular rash and red rash. On an unknown date, the outcome of the rash, pruritus, varicella-like rash, joint pain, papular rash and red rash were unknown.   It was unknown if the reporter considered the rash, pruritus, varicella-like rash, joint pain, papular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and around 1st week of December, he started experiencing rash and itching on back, shoulder, chest, forehead and face.The rash has turned into bumps and the itching was getting better.He also experienced chicken pox looking like spots on shoulder and back.They have not started spreading to the side of the body, and his buttock area. It was also starting to affect his eye. He breaks out and it clears up and comes back in another spot. He also experienced joint pain that lasted for about 3 weeks. He visited his doctor regarding his experience and was directed to contact his pharmacy. Around one week after the injection he started developing overall itching.  Around one week after the injection he started developing overall itching. About the second week he also developed rash, joint pain, spots broke out on his back, hair was itching, rash around his eye, chest and face, forehead and nose.The patient cannot use shampoo because it would set his symptoms on fire.The patient still had all the symptoms.Symptoms are not as bad, but he still had them. The reporter consented to follow up. No further details were provided.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Chicken pox like spots/spots broke out on his back/; Joint pain; rash has now turned into bumps/red rash with little bumps; red rash; Rash on back/ shoulder/chest/forehead/face/around eyes/nose; itching on back/shoulder/chest/forehead/face/hair was itching/overall itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On 20th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2019, 7 days after receiving Shingrix, the patient experienced pruritus. On 4th December 2019, the patient experienced rash, varicella-like rash, joint pain, papular rash and red rash. On an unknown date, the outcome of the rash, pruritus, varicella-like rash, joint pain, papular rash and red rash were unknown.   It was unknown if the reporter considered the rash, pruritus, varicella-like rash, joint pain, papular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and around 1st week of December, he started experiencing rash and itching on back, shoulder, chest, forehead and face.The rash has turned into bumps and the itching was getting better.He also experienced chicken pox looking like spots on shoulder and back.They have not started spreading to the side of the body, and his buttock area. It was also starting to affect his eye. He breaks out and it clears up and comes back in another spot. He also experienced joint pain that lasted for about 3 weeks. He visited his doctor regarding his experience and was directed to contact his pharmacy. Around one week after the injection he started developing overall itching.  Around one week after the injection he started developing overall itching. About the second week he also developed rash, joint pain, spots broke out on his back, hair was itching, rash around his eye, chest and face, forehead and nose.The patient cannot use shampoo because it would set his symptoms on fire.The patient still had all the symptoms.Symptoms are not as bad, but he still had them. The reporter consented to follow up. No further details were provided.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye oedema, Eye swelling
Clinical narrative: swelling; Area appeared filled with fluid; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 1st dose of Shingrix. In December 2019, 36 hrs after receiving Shingrix, the patient experienced eye swelling and edema. On an unknown date, the outcome of the eye swelling and edema were recovering/resolving.   It was unknown if the reporter considered the eye swelling and edema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient had swelling under both eyes and area appeared filled with fluid. The patient observed when woke up at 4 am on tuesday morning, but thought that it started in the night before. Till the time of reporting, the eye swelling and edema were recovering but not completely resolved. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous, Urticaria
Clinical narrative: red spots that look like hives across her back and on her belly/ a tiny round welt; red spots; This case was reported by a consumer via call center representative and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced hives and red spotty rash. On an unknown date, the outcome of the hives and red spotty rash were recovered/resolved.   It was unknown if the reporter considered the hives and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingix in the left arm. The patient reported that, had red spot that look like hives appeared across her back and on her belly. The res spot came and went sometime when sat in a chair it creates a red streak across her back. A spot the size of a 50 cent piece appeared on her belly. The red spot resolved but then cames back. The patient also reported that, experienced a tiny round welt the size of a pencil eraser on her belly sometimes. It usually occurs in the evening.  The spots last for an half and hour before resolving.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: headache; tingling on face; numbness on her face; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on face in 2013).   On 19th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th September 2019, 1 day after receiving Shingrix, the patient experienced headache, tingling and numbness facial. On an unknown date, the outcome of the headache, tingling and numbness facial were recovered/resolved.   It was unknown if the reporter considered the headache, tingling and numbness facial to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced headache. She also noticed numbness and tingling on face where she previously had shingles.   It lasted a couple of days and symptoms appeared very quickly, on the day of vaccination. The pharmacist was transferred to MI for questions as patient was concerned about getting her second dose of shingrix after her experience.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Developed a non- itchy macular red rash on her chest; This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a female patient who received Herpes zoster (Shingrix) 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 erythromacular rash. On an unknown date, the outcome of the erythromacular rash was unknown.   It was unknown if the reporter considered the erythromacular rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient developed a non- itchy macular red rash but stated that it was not hive located on her chest. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Pain in the injected arm; Nerve pain; shooting pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2019, the patient received the 1st dose of Shingrix. On 22nd December 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, nerve pain and shooting pain. On an unknown date, the outcome of the pain in arm, nerve pain and shooting pain were recovering/resolving.   It was unknown if the reporter considered the pain in arm, nerve pain and shooting pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced pain in the injected arm the day after receiving the vaccine.  The pain has improved but he still experiences a shooting pain when he moves his hand a certain way or makes a sudden movement.   He described it as nerve pain.   It goes away quickly but it was annoying. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling hot, Grip strength decreased, Injection site erythema, Injection site pain
Clinical narrative: Around the injection site arm was warm; Around the injection site arm was red; Around the injection site arm was tender; Stiff fingers on left hand, and stiffness extended through hand and wrist; Wrist is still tender and painful/ elbow pain; Wrist is hot around stiffness; Cannot close hand all the way; Has lost grip strength; Pain extends from wrist to shoulder and elbow; Swelling in wrist has not gone down and extends to fingers; Radiating pain; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number AA3K4, expiry date 6th December 2021) for prophylaxis.   Previously administered products included Shingles vaccine (received shingles shot on an unknown date).   On 14th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, 1 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site pain. In October 2019, the patient experienced limbs stiffness, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site pain, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain were unknown and the outcome of the limbs stiffness was recovering/resolving.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site pain, limbs stiffness, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's husband. The reporter stated that the patient experienced around the injection site arm was warm, red and tender approximately 2 quarters around. The reporter stated that placing palm on arm and feeling warmth on palm. The reporter stated that the patient woke up with stiff fingers on left hand, and stiffness extended through hand and wrist. The reporter stated that the hand pain became progressively painful and worse and wrist was tender and painful and hot around stiffness. The reporter stated that the patient could not close hand all the way and that she had lost grip strength, finger pads are tender to touch, and pain extends from wrist to shoulder and elbow. The reporter stated that the swelling in the patient's wrist has not gone down and extends to fingers including pinky and left wrist was noticeably larger. The patient also had intermittent shooting pain to shoulder as well. This case has been linked with case US2020AMR006218 and US2020AMR006219, reported for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Joint swelling, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Around the injection site arm was warm; Around the injection site arm was red; Around the injection site arm was tender; Stiff fingers on left hand, and stiffness extended through hand and wrist; Wrist is still tender and painful/ elbow pain; Wrist is hot around stiffness; Cannot close hand all the way; Has lost grip strength; Pain extends from wrist to shoulder and elbow; Swelling in wrist has not gone down and extends to fingers; Radiating pain; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number AA3K4, expiry date 6th December 2021) for prophylaxis.   Previously administered products included Shingles vaccine (received shingles shot on an unknown date).   On 14th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, 1 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site pain. In October 2019, the patient experienced limbs stiffness, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site pain, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain were unknown and the outcome of the limbs stiffness was recovering/resolving.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site pain, limbs stiffness, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's husband. The reporter stated that the patient experienced around the injection site arm was warm, red and tender approximately 2 quarters around. The reporter stated that placing palm on arm and feeling warmth on palm. The reporter stated that the patient woke up with stiff fingers on left hand, and stiffness extended through hand and wrist. The reporter stated that the hand pain became progressively painful and worse and wrist was tender and painful and hot around stiffness. The reporter stated that the patient could not close hand all the way and that she had lost grip strength, finger pads are tender to touch, and pain extends from wrist to shoulder and elbow. The reporter stated that the swelling in the patient's wrist has not gone down and extends to fingers including pinky and left wrist was noticeably larger. The patient also had intermittent shooting pain to shoulder as well. This case has been linked with case US2020AMR006218 and US2020AMR006219, reported for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Around the injection site arm was warm; Around the injection site arm was red; Around the injection site arm was tender; Stiff fingers on left hand, and stiffness extended through hand and wrist; Wrist is still tender and painful/ elbow pain; Wrist is hot around stiffness; Cannot close hand all the way; Has lost grip strength; Pain extends from wrist to shoulder and elbow; Swelling in wrist has not gone down and extends to fingers; Radiating pain; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number AA3K4, expiry date 6th December 2021) for prophylaxis.   Previously administered products included Shingles vaccine (received shingles shot on an unknown date).   On 14th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, 1 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site pain. In October 2019, the patient experienced limbs stiffness, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site pain, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain were unknown and the outcome of the limbs stiffness was recovering/resolving.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site pain, limbs stiffness, wrist pain, feeling of warmth, mobility decreased, grip strength decreased, shoulder pain, swelling of wrists and radiating pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's husband. The reporter stated that the patient experienced around the injection site arm was warm, red and tender approximately 2 quarters around. The reporter stated that placing palm on arm and feeling warmth on palm. The reporter stated that the patient woke up with stiff fingers on left hand, and stiffness extended through hand and wrist. The reporter stated that the hand pain became progressively painful and worse and wrist was tender and painful and hot around stiffness. The reporter stated that the patient could not close hand all the way and that she had lost grip strength, finger pads are tender to touch, and pain extends from wrist to shoulder and elbow. The reporter stated that the swelling in the patient's wrist has not gone down and extends to fingers including pinky and left wrist was noticeably larger. The patient also had intermittent shooting pain to shoulder as well. This case has been linked with case US2020AMR006218 and US2020AMR006219, reported for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Death, Deep vein thrombosis, Erythema, Eyelid margin crusting
Clinical narrative: DVT; Pneumonia; Pharmacist states the patient's death; forehead redness; forehead; crusting of the eyes; Ocular shingles; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis.   Co-suspect products included erythromycin (Erythromycin Ointment) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Erythromycin Ointment at an unknown dose and frequency. In May 2019, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On 22nd May 2019, the patient experienced erythema, blister and eye crusting. On 15th December 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and pneumonia (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and artificial tears nos (Artificial Tears). Erythromycin Ointment was discontinued. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting were unknown. The patient died on 15th December 2019. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix developed ocular shingles within one week. The medical team were unsure if it was herpes, but the chart notes not clearly bacterial or viral. Patient was prescribed erythromycin ointment for prophylaxis, then on 22nd May 2019 started getting forehead redness and blisters, crusting of the eyes, and she stopped erythromycin.The treatment was changed to artificial tears and started Valcyclovir 1g, 1 BID for 10 days. Patient had consult with ophthalmology and was treated with artificial tears. The consult noted "no evidence of herpetic uvelitis, keratitis, or retinitis in right eye and a treatment with antiviral medication was continue. On 15th December 2019, the patient died exact cause of death unknown. The patient had multiple issues including DVT and pneumonia, and patient elected for comfort care instead of treatment. Pharmacist states the patient's death does not appear to be related to Shingrix.; Reported Cause(s) of Death: Death
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pneumonia
Clinical narrative: DVT; Pneumonia; Pharmacist states the patient's death; forehead redness; forehead; crusting of the eyes; Ocular shingles; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis.   Co-suspect products included erythromycin (Erythromycin Ointment) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Erythromycin Ointment at an unknown dose and frequency. In May 2019, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On 22nd May 2019, the patient experienced erythema, blister and eye crusting. On 15th December 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and pneumonia (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and artificial tears nos (Artificial Tears). Erythromycin Ointment was discontinued. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting were unknown. The patient died on 15th December 2019. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix developed ocular shingles within one week. The medical team were unsure if it was herpes, but the chart notes not clearly bacterial or viral. Patient was prescribed erythromycin ointment for prophylaxis, then on 22nd May 2019 started getting forehead redness and blisters, crusting of the eyes, and she stopped erythromycin.The treatment was changed to artificial tears and started Valcyclovir 1g, 1 BID for 10 days. Patient had consult with ophthalmology and was treated with artificial tears. The consult noted "no evidence of herpetic uvelitis, keratitis, or retinitis in right eye and a treatment with antiviral medication was continue. On 15th December 2019, the patient died exact cause of death unknown. The patient had multiple issues including DVT and pneumonia, and patient elected for comfort care instead of treatment. Pharmacist states the patient's death does not appear to be related to Shingrix.; Reported Cause(s) of Death: Death
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cerebral haemorrhage, Computerised tomogram head, Concussion, Electrocardiogram
Clinical narrative: sudden loss of consciousness, hypotension, fall resulting in concussion and frontal lobe bleed
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Hypotension, Loss of consciousness
Clinical narrative: sudden loss of consciousness, hypotension, fall resulting in concussion and frontal lobe bleed
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Fall, Head injury, Headache, Incontinence
Clinical narrative: After receiving vaccine patient was sitting on dad's lap, patient fainted and fell off of dad's lap, hit head on wall and floor.   Parents picked patient up and placed on treatment table, this nurse called for Dr. to come to room, patient then had episode of incontinence and awoke, crying. C/o of head hurting.   HR of 102 and BP of 124/86 taken per MA.   DR monitoring patient.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: After receiving vaccine patient was sitting on dad's lap, patient fainted and fell off of dad's lap, hit head on wall and floor.   Parents picked patient up and placed on treatment table, this nurse called for Dr. to come to room, patient then had episode of incontinence and awoke, crying. C/o of head hurting.   HR of 102 and BP of 124/86 taken per MA.   DR monitoring patient.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Dry skin, Eczema, Rash erythematous
Clinical narrative: Developed a dry, red rash that I was told was eczema within 48 hours of the vaccine
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Skin warm
Clinical narrative: arm got red, swelled up and got very hot. patient also had a headache
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Mom states patient had fever of 104 & muscle stiffness where she could not bend down for 24 hours after vaccine
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: SORE ARM STARTING FROM 1 WEEK AFTER INJECTION AND PAIN HAS GOTTEN WORSE TO DATE
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Injection site turned red. Patient experienced flu like symptoms
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: seizure like activity and syncope; syncope; This spontaneous report was received from a nurse prescriber via a company representative and refers to a currently 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis (recommended by Centers for Disease Control and Prevention (CDC)). On an unknown date (reported as after receiving a first dose), the patient experienced seizure like activity and syncope. The patient sought medical attention. She was in the office. As a treatment, she had her legs elevated, making her comfortable. The outcome of seizure like activity and syncope was reported as recovered/resolved (unspecified date). The causality assessment between suspect therapy and the events was not provided by the reporter.  Upon internal review, both events were considered to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported; patient received an expired dose of M-M-R II; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 14-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5ml, once, lot# R00556, expiration date 08-JAN-2020; route of administration were not reported) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot# S024968, expiration date 28-FEB-2022). No additional adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: the patient experienced swelling and pain in the left deltoid where the dose was administered; the patient experienced swelling and pain in the left deltoid where the dose was administered; This spontaneous report was received from a nurse via a company representative and refers to a currently 17-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly in the left deltoid (exact dose, lot # and expiration date were not reported) for human papilloma virus (HPV) prevention. On an unknown date after the administration of the dose, the patient experienced swelling and pain in the left deltoid where the dose was administered. The patient sought medical attention by visiting the office. No treatment was given for the events. The outcome of injection site swelling and injection site pain was reported as recovering/resolving. No causality assessment was provided by the reporter.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia, Pulmonary congestion, Pyrexia
Clinical narrative: Got a vaccine for pneumonia and within a week I had the disease/I was in the hospital with pneumonia.; Inappropriate dose of vaccine administered; The initial case was missing the following minimum criteria: the suspect product is not reported or specified. Upon receipt of follow-up information on 08Jan2020, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer from a Pfizer sponsored program.  A 66-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) via an unspecified route of administration at single dose on an unspecified dose for immunisation, recommended at a regular check-up.  The patient medical history and concomitant medications were not reported.  The patient got a vaccine for pneumonia and within a week he had the disease, he was in the hospital with pneumonia on an unspecified date. The outcome of the event was unknown. He thought just coincidence. The following year the same thing occurred. One week after the shot, in went to emergency room with pneumonia. High fever, lungs plugged, the whole thing. He knew that he was at risk for the disease but he was not sure the vaccine was giving me the disease or not. The only thing he knew about the vaccine was it was number 13. He won't get another.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: PPV, UNK
Symptoms: Malaise
Clinical narrative: getting sick; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunization, influenza vaccine (FLU VACCINE VII), via an unspecified route of administration on an unspecified date at unknown dose for immunization. Medical history included ulcerative colitis. Concomitant medication included infliximab (REMICADE) for ulcerative colitis, vedolizumab (ENTYVIO) for ulcerative colitis. Being switched from vedolizumab for treatment of ulcerative colitis to infliximab for treatment of ulcerative colitis after taking vedolizumab for a couple of years. The reporter reported receiving a flu shot and pneumonia shot but still getting sick when going out while taking infliximab on an unspecified date. The outcome of event was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Emotional distress, Epistaxis, Fall, Lip injury
Clinical narrative: Shortly after administration of the Gardasil 9 vaccine, patient experienced what seems to be a vasovagal episode and fell to the ground. He sustained a bloody nose as well as a laceration to his bottom lip as a result of the fall. On the floor, patient had his eyes open, but he did not speak and experienced tonic-clonic movements in his upper extremities, which lasted a few seconds (~5  sec) before recovery. The fall was witnessed by his father. Patient was visibly distraught after the incident with a bloody nose as well as a bloody mouth from his fall to the floor. Tissue was given to patient to help stop his bloody nose as well as water to drink. On exam, patient did have ~1 cm vertical laceration to his left inner lower lip, which stopped bleeding. He was able to drink water as well as suck on a popsicle. Patient remained coherent and remembered what he had for breakfast and lunch that day as well as his activities for later that day (a friend's birthday party at a bounce house). Patient was advised not to attend the party and to limit his activities for the next week and to follow up in 1-2 weeks in our office for reevaluation, sooner if things worsened.   Attempts made to contact the family on 1/18/20. Family contacted on 1/19/20 - Patient feeling better with a decrease in his lip swelling. He was still having some bloody noses, which stopped quickly with pressure. Appetite still slightly decreased. No reported difficulty with breathing. Advised family to have Patient avoid soccer activities for the next week until reevaluation.  Parents understood plan.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Lip swelling, Loss of personal independence in daily activities, Presyncope, Tonic clonic movements
Clinical narrative: Shortly after administration of the Gardasil 9 vaccine, patient experienced what seems to be a vasovagal episode and fell to the ground. He sustained a bloody nose as well as a laceration to his bottom lip as a result of the fall. On the floor, patient had his eyes open, but he did not speak and experienced tonic-clonic movements in his upper extremities, which lasted a few seconds (~5  sec) before recovery. The fall was witnessed by his father. Patient was visibly distraught after the incident with a bloody nose as well as a bloody mouth from his fall to the floor. Tissue was given to patient to help stop his bloody nose as well as water to drink. On exam, patient did have ~1 cm vertical laceration to his left inner lower lip, which stopped bleeding. He was able to drink water as well as suck on a popsicle. Patient remained coherent and remembered what he had for breakfast and lunch that day as well as his activities for later that day (a friend's birthday party at a bounce house). Patient was advised not to attend the party and to limit his activities for the next week and to follow up in 1-2 weeks in our office for reevaluation, sooner if things worsened.   Attempts made to contact the family on 1/18/20. Family contacted on 1/19/20 - Patient feeling better with a decrease in his lip swelling. He was still having some bloody noses, which stopped quickly with pressure. Appetite still slightly decreased. No reported difficulty with breathing. Advised family to have Patient avoid soccer activities for the next week until reevaluation.  Parents understood plan.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain
Clinical narrative: Pain in the upper left arm. Not a continuous pain but life a sharp nerve pain.  Will sometime goes around the shoulder and into my back
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Headache, Immediate post-injection reaction, Neck pain, Tremor
Clinical narrative: Pt states immediately after getting the flu vaccine she felt like she was shaking, confused and pain from her neck up to her head. This lasted for about 5 minutes and symptoms never returned. -administered at pharmacy.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: My son received the first 2 doses of GARDASIL when he was 14 years old and then received the third dose of the series as GARDASIL 9 when he was 17 years old; My son received the first 2 doses of GARDASIL when he was 14 years old and then received the third dose of the series as GARDASIL 9 when he was 17 years old; No additional adverse effect reported; This spontaneous report was received from the patient's father referring to his 17 year old son. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On unknown dates, when the patient was 14 years old, he was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on an unspecified date, when he was 17 years old, the patient received the third dose of the series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot # and expiration date were not provided). No adverse effects were reported.
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase increased, Basophil count decreased
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Blood calcium normal, Blood chloride increased, Blood creatine phosphokinase increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Blood urine present, C-reactive protein normal
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Chest pain, Chromaturia, Eosinophil count decreased, Eosinophil percentage, Glomerular filtration rate
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Glucose urine absent, Granulocyte percentage, Haematocrit normal, Haemoglobin normal, International normalised ratio increased
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Joint range of motion decreased, Lymphocyte count decreased, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Monocyte percentage increased, Myalgia
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Neutrophil count normal, Nitrite urine absent, Platelet count normal, Protein total normal, Protein urine absent
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Prothrombin time prolonged, Red blood cell count normal, Red blood cell sedimentation rate normal, Red blood cells urine negative, Red cell distribution width normal
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Rhabdomyolysis, Specific gravity urine normal, Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 18.0
Sex: M
Vaccine: ANTH, FLU4, JEV1, MMR, VARCEL
Symptoms: Urobilinogen urine decreased, White blood cell count normal, White blood cells urine positive, pH urine normal
Clinical narrative: myalgias, decreased range of motion, chest pain, rhabdoymyolysis with creatinine kinase >20,000
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Swelling and pain at the injection site and felt warm to touch for two days; aching in every joint in my body for two days, felt feverish and had chills, malaise
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Swelling and pain at the injection site and felt warm to touch for two days; aching in every joint in my body for two days, felt feverish and had chills, malaise
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure decreased, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Had the shot 10 am. At 7 pm felt fatigued , a bit of an upset stomach. The following day was tired, had a headache (I very rarely have a headache!) and around 5 pm had severe chills , my chin couldn?t stop shaking. And muscle aches . Then bad diahreah came on quickly and continued from 9 pm to 4:00 am at which time is got very dizzy , then blacked out and woke up with my face on the carpet. Then projectile vomited five times while I was calling 911 as I was alone at the house and didn?t want to pass out again. Taken by ambulance to emergency room. Temp was 100.1. Given 2 x 1000  cc water intervenously. Was released at 8 am - still very nauseated , but better , took one zophran through out that day. Continued to be severely fatigued but no fever . Was in bed for the following three days due to fatigue.  I write down everything I eat so reviewed and all was normal stuff that my husband had also eaten and I hadn?t gone out to eat for several days prior. I had a reaction to the first shingles shot though not as severe. Was fatigued for two days and upset stomach with first shot. Never had reactions to any other shots .
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Face injury, Fall, Fatigue
Clinical narrative: Had the shot 10 am. At 7 pm felt fatigued , a bit of an upset stomach. The following day was tired, had a headache (I very rarely have a headache!) and around 5 pm had severe chills , my chin couldn?t stop shaking. And muscle aches . Then bad diahreah came on quickly and continued from 9 pm to 4:00 am at which time is got very dizzy , then blacked out and woke up with my face on the carpet. Then projectile vomited five times while I was calling 911 as I was alone at the house and didn?t want to pass out again. Taken by ambulance to emergency room. Temp was 100.1. Given 2 x 1000  cc water intervenously. Was released at 8 am - still very nauseated , but better , took one zophran through out that day. Continued to be severely fatigued but no fever . Was in bed for the following three days due to fatigue.  I write down everything I eat so reviewed and all was normal stuff that my husband had also eaten and I hadn?t gone out to eat for several days prior. I had a reaction to the first shingles shot though not as severe. Was fatigued for two days and upset stomach with first shot. Never had reactions to any other shots .
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Loss of consciousness, Myalgia, Nausea, Tremor
Clinical narrative: Had the shot 10 am. At 7 pm felt fatigued , a bit of an upset stomach. The following day was tired, had a headache (I very rarely have a headache!) and around 5 pm had severe chills , my chin couldn?t stop shaking. And muscle aches . Then bad diahreah came on quickly and continued from 9 pm to 4:00 am at which time is got very dizzy , then blacked out and woke up with my face on the carpet. Then projectile vomited five times while I was calling 911 as I was alone at the house and didn?t want to pass out again. Taken by ambulance to emergency room. Temp was 100.1. Given 2 x 1000  cc water intervenously. Was released at 8 am - still very nauseated , but better , took one zophran through out that day. Continued to be severely fatigued but no fever . Was in bed for the following three days due to fatigue.  I write down everything I eat so reviewed and all was normal stuff that my husband had also eaten and I hadn?t gone out to eat for several days prior. I had a reaction to the first shingles shot though not as severe. Was fatigued for two days and upset stomach with first shot. Never had reactions to any other shots .