chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: heart attack; congestive heart failure; sepsis; pneumonia; edema of the lungs; viral infection; other injuries; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-JAN-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the clinic for routine health maintenance and for the prevention of shingles (herpes zoster). In early May 2018 (also reported as shortly after vaccination), the patient suffered a heart attack, congestive heart failure, sepsis, pneumonia, and other injuries and edema of the lungs as a result of viral infection caused by zoster vaccine live (ZOSTAVAX). These life-threatening conditions resulted in prolonged hospitalization and extensive medical history, excluding but not limited to a heart catheterization and a coronary angiogram. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, she suffered severe injuries and life-long disabilities not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and suffered economic losses due to her inability to work. The patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence, she suffered serious, progressive, 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, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The events of heart attack, congestive heart failure, sepsis, pneumonia, other injuries and edema of the lungs as a result of viral infection were considered to be disabling and life threatening. Upon internal review, the events of heart attack, congestive heart failure, sepsis, pneumonia and edema of the lungs were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Pain at injection site; Redness at injection site; blotchy at injection site; Itchiness at injection site; Fever; Fatigue; Aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received on unknown date, refer case US2019190822).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was a coworker. The reporter did not provide patient initial, date of birth or healthcare professional details. The patient received vaccine in unknown arm. The patient developed fever, pain at the injection site, aches, and fatigue and also developed itchiness, redness, and blotches at the injection site. The patient's symptoms lasted for a few days before resolving. The reporter had limited information regarding this adverse event. The reporter consent to follow up. This case had been linked to the case US2019190821, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash macular, Vaccine positive rechallenge
Clinical narrative: Pain at injection site; Redness at injection site; blotchy at injection site; Itchiness at injection site; Fever; Fatigue; Aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received on unknown date, refer case US2019190822).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was a coworker. The reporter did not provide patient initial, date of birth or healthcare professional details. The patient received vaccine in unknown arm. The patient developed fever, pain at the injection site, aches, and fatigue and also developed itchiness, redness, and blotches at the injection site. The patient's symptoms lasted for a few days before resolving. The reporter had limited information regarding this adverse event. The reporter consent to follow up. This case had been linked to the case US2019190821, reported by same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Supraventricular tachycardia
Clinical narrative: Supraventricular Tachycardia; This case was reported by a other health professional via sales rep and described the occurrence of supraventricular tachycardia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced supraventricular tachycardia. On an unknown date, the outcome of the supraventricular tachycardia was unknown.   It was unknown if the reporter considered the supraventricular tachycardia to be related to Shingrix.  Additional details were provided as follows: The reporter stated that patient experienced  supraventricular tachycardia. The reporter stated that oncologist following the patient. The reporter consented to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019AMR192595.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperplasia
Clinical narrative: Potential Hyperplastic reaction; This case was reported by a other health professional via sales rep and described the occurrence of hyperplasia in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of supraventricular tachycardia (received 1st dose in February or march 2019 and experienced SVT).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced hyperplasia. On an unknown date, the outcome of the hyperplasia was unknown.   It was unknown if the reporter considered the hyperplasia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 2nd dose experienced potential Hyperplastic reaction. The reporter stated that oncologist following the patient. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash, Rash erythematous
Clinical narrative: Rash; Rash; Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, red rash and rash. On an unknown date, the outcome of the influenza-like symptoms, red rash and rash were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, red rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had flu like for 3 days. The patient had rash with large red circle on arms back and chest. For tolerance to 2nd dose, refer linked case US2019AMR191591.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Local Reaction with Erythema noted 10/26/19. Treated with oral ibuprofen & benadryl
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site induration, Injection site pain, Malaise, Musculoskeletal pain
Clinical narrative: Redness traveled down arm Injection site sore and hard for 2 days. Pain that traveled to shoulder. Became sick for 2 days
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Arthralgia, Dyspnoea, Headache, Nausea, Speech disorder
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Visual field defect, Visual impairment
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Aphasia, Arthralgia, Chest discomfort, Disturbance in attention, Dizziness
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Dysarthria, Dyspnoea, Flank pain, Headache, Hypoaesthesia
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Injection site pain, Loss of personal independence in daily activities, Migraine, Nail discolouration, Nausea
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Pain, Pharyngeal swelling, Pollakiuria, Poor peripheral circulation, Skin discolouration
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 16.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Speech disorder, Swollen tongue, Throat tightness, Urine output increased, Vision blurred
Clinical narrative: 16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large erythematous, raised patch; very warm to touch and painful. Area progressed to entire size of right upper ant thigh and spread around to partial post thigh.  Pt did not want to bear wt.  Fever to 102f
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt called to report she was experiencing pain and swelling at the injection site.  Patient was advised to move her arm around, take Tylenol/Motrin for soreness and use a a warm compress to the site.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting on 9/29/2019 followed by fever ranging from 101-103 for the next 4 days. No other symptoms with fever.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Chills, severe shakes, teeth shattering shakes for over an hour.  Fever, head and neck hurt, felt nauseous. The next day, still running fever, felt like I had been run over by a truck.  Head, neck and back ached.  Wanted to stay in bed and sleep.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Influenza, Influenza virus test negative, Nausea, Neck pain, Pyrexia
Clinical narrative: Chills, severe shakes, teeth shattering shakes for over an hour.  Fever, head and neck hurt, felt nauseous. The next day, still running fever, felt like I had been run over by a truck.  Head, neck and back ached.  Wanted to stay in bed and sleep.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Somnolence, Tremor
Clinical narrative: Chills, severe shakes, teeth shattering shakes for over an hour.  Fever, head and neck hurt, felt nauseous. The next day, still running fever, felt like I had been run over by a truck.  Head, neck and back ached.  Wanted to stay in bed and sleep.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Cytokine storm, Decreased appetite, Malaise, Myalgia, Pyrexia
Clinical narrative: Cytokines storm with muscle pain, malaise, wheezing, loss of appetite, low grade fever   All lasted 10 days
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Cytokines storm with muscle pain, malaise, wheezing, loss of appetite, low grade fever   All lasted 10 days
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: 10 cm diameter dark red discoloration around injection site, slightly swollen and painful, elevated temperature, malaise, fatigue
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise
Clinical narrative: 10 cm diameter dark red discoloration around injection site, slightly swollen and painful, elevated temperature, malaise, fatigue
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: I got the shivers which were so extreme I had to hold my jaw shut to not break my teeth. This lasted about two hours and then slowly went into a fever for a two hours and then I relaxed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Secretion discharge
Clinical narrative: 100 degree fever for 24 hours, lengthy (1 hour) mucous discharge from nose 10 hours after injection, pain in arm 3 days. Ibuprofen for pain/fever.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Large local reaction
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Emotional distress, Screaming, Sleep terror, Somnolence
Clinical narrative: Patient was put to bed as normal the night of the vaccination.  A few hours after going to sleep, he began flailing and screaming,  became inconsolable,   yet I was unable to fully wake him.  Once he would get calm, the episode would reoccur every 10-30 minutes the remainder of the night.  This became the "norm" for the next approximately 1.5 years until he stopped receiving this vaccination.  His sleep would slowly improve until the next DTaP vaccination, and the cycle would restart. The rest of his DTap schedule is as follows: #3- 7/9/14 #4- 6/25/15  Approximately 6 months after the last vaccination on 6/25/15, Patient stopped having these "night terror"-like events and was sleeping well through the night.  He has not had any other similar sleeping issue since then.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Swelling
Clinical narrative: Left arm was sore for 2 days, then resolved, then muscle soreness and mild swelling returned after 2 weeks.  No redness, heat, or open areas.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Insomnia, Malaise, Myalgia
Clinical narrative: Not sure if I have the 'lot number,' correct.  I took it off of the receipt the clinic gave me.      Five hours after receiving injection, I felt ill and muscles began to ache.  Eight hours after injection, I went to bed, but could not sleep as had chills then sweating, heart racing for the next 10 hours.  Felt like I was on speed with serious muscle aches throughout my body. Nineteen hours after injection, I was able to get some good sleep for a few hours.  Twenty-three hours after injection I'm still feeling a bit achy and sluggish, but was able to go to work.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Palpitations, Sluggishness
Clinical narrative: Not sure if I have the 'lot number,' correct.  I took it off of the receipt the clinic gave me.      Five hours after receiving injection, I felt ill and muscles began to ache.  Eight hours after injection, I went to bed, but could not sleep as had chills then sweating, heart racing for the next 10 hours.  Felt like I was on speed with serious muscle aches throughout my body. Nineteen hours after injection, I was able to get some good sleep for a few hours.  Twenty-three hours after injection I'm still feeling a bit achy and sluggish, but was able to go to work.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Outbreak of right face/scalp dermatomal blistering rash that improved after prednisone and valtrex.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Whelp appeared on left arm below the injection site of the MMR. Diluent used was Merck R032354 EXP 6-11-2021 Whelp was .5 cm in size. redness noted around whelp. Advised to apply ice and give antihistamine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Gait inability, Pain in extremity
Clinical narrative: Pt. c/o not being able to walk, stated both of her legs very painful.  Pt remained in office for approx. 1 hour and was able to walk to her car.  Called back the next day stating that her legs were still sore but she was significantly improved.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Limb discomfort
Clinical narrative: Client reports range of motion is limited in her left arm. Reports "it felt like an emersion grinder". Reports "it feels like a rip is in there". Reports she alternated Tylenol and Ibuprofen the first 3 days. Denies using heat or ice at immunization site.
Age: 68.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Renal pain, Urinary tract infection
Clinical narrative: Patient reports "kidney pain" that began one day after receiving these vaccines and continues today, 10 days after vaccine. Patient does not report any signs or symptoms of UTI and requests that this adverse event be reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelids pruritus, Swelling of eyelid
Clinical narrative: 2 1/2 hours  after vaccination, developed swollen itchy eyelids (bilateral, upper & lower). Applied warm compresses, took Benadryl with relief of symptoms.  No difficulty breathing.  Took one more Benadryl 4 hours later prior to bedtime.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain, and warmth at injection site with some redness and pain down the arm beginning the day after administration.  Patient has had significant improvement but has not had complete resolution.  There is still some redness and swelling at and near the injection site and some redness just below. She will seek medical attention if there is not continued improvement or complete resolution.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Redness, swelling, pain, and warmth at injection site with some redness and pain down the arm beginning the day after administration.  Patient has had significant improvement but has not had complete resolution.  There is still some redness and swelling at and near the injection site and some redness just below. She will seek medical attention if there is not continued improvement or complete resolution.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: received improperly stored vaccine; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) one dose, lot # S003865 and expiration date: 08-AUG-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in 32.5 Fahrenheit (F) for 8 hours. There was no previous temperature excursion. The temperature excursion was recorded by digital data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: hearing loss; vision loss; paralysis and numbness of the face; severe pain; paralysis and numbness of the face; constant and severe ringing in ears; other neurologic injuries and episodes; headaches; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 07-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Approximately one or two weeks after receiving zoster vaccine live (ZOSTAVAX), patient suffered debilitating injuries including severe pain and paralysis and numbness of the face; constant and severe ringing in ears and hearing loss; headaches; vision loss and other neurologic injuries and episodes. All of these injuries were caused by the zoster vaccine live (ZOSTAVAX)injection. These severe, painful and debilitating injuries "continue today". As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the zoster vaccine live (ZOSTAVAX) vaccine. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries and suffered serious, progressive, 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 zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, vision loss, hearing loss and paralysis of the face were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Neurological symptom, Pain, Tinnitus
Clinical narrative: hearing loss; vision loss; paralysis and numbness of the face; severe pain; paralysis and numbness of the face; constant and severe ringing in ears; other neurologic injuries and episodes; headaches; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 07-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Approximately one or two weeks after receiving zoster vaccine live (ZOSTAVAX), patient suffered debilitating injuries including severe pain and paralysis and numbness of the face; constant and severe ringing in ears and hearing loss; headaches; vision loss and other neurologic injuries and episodes. All of these injuries were caused by the zoster vaccine live (ZOSTAVAX)injection. These severe, painful and debilitating injuries "continue today". As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the zoster vaccine live (ZOSTAVAX) vaccine. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries and suffered serious, progressive, 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 zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, vision loss, hearing loss and paralysis of the face were considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: ringing in the ears; This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 525NP, expiry date 4th September 2021) for prophylaxis.   On 22nd October 2019, the patient received Boostrix .5 ml. On 22nd October 2019, less than a day after receiving Boostrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Boostrix.  Additional information received were as follows: In the morning, the patient received a dose of Boostrix in an unknown arm and developed ringing in the ears sometime after receiving the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 76-year-old patient who received Herpes zoster (Shingrix) (batch number 27KF5, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced myalgia since their first dose of Shingrix.  The muscle pain had been present for 5 months after first dose. The patient asked how long do myalgias last after Shingrix injection.  No other information was provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergy to Cephalosporin).   On 18th October 2019, the patient received Boostrix. On 18th October 2019, less than a day after receiving Boostrix, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Boostrix on the left arm and that evening, she experienced hives.  The reporter could not confirm where the hives originated. The patient took Benadryl and she got better.  After the Benadryl medication wore off, her hives returned so she took Benadryl again and she was fine at the reporting date. The reporter consented to follow up. The age group and outcome of events reported in the database was does not match with that reported in the source document.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: she had Pneumonia twice within the last 18 months; she had Pneumonia twice within the last 18 months; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 25Oct2019, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer reported for herself.   A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunization on unknown date. relevant medical history and concomitant medications were not reported. The patient had Pneumonia twice within the last 18 months. the outcome of the event was unknown.   Information about batch number was not available and is going to be requested.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Chills, Injection site pain, Pruritus, Pyrexia, Skin lesion
Clinical narrative: Itchy lesions all over his body-legs, arms, abdomen; One day post vaccination patient reported pain at injection of Prevnar 13; fever; chills; This is a spontaneous report from a   physician. This report was received via a sales representative.   A 65-years-old male patient receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , in the arm on 03Oct2019 at single dose for immunisation , influenza vaccine (INFLUENZA) , via an unspecified route of administration on 03Oct2019 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient reported pain at injection of Prevnar 13  on 04Oct2019 with outcome of recovering , fever on 04Oct2019 with outcome of recovering , chills on 04Oct2019 with outcome of recovering , itchy lesions all over his body-legs, arms, abdomen  on 21Oct2019 with outcome of recovering.    The Patient was treated with oral steroids and OTC Benadryl at night. Patient starting to feel better.  The information on the batch number has been requested
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Mobility decreased, Neuropathy peripheral, Pain in extremity
Clinical narrative: Arm pain with neuropathy like symptoms on right upper arm; Arm pain with neuropathy like symptoms on right upper arm; Achiness in his chest; Had a problem initially closing his hand; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 25Oct2019, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer. A 68-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# Y03623), via an unspecified route of administration in the right arm, on 18Sep2019, at 0.5 ml single, for immunisation. Medical history and concomitant medications were none. The patient experienced arm pain with neuropathy like symptoms on right upper arm, achiness in his chest, had a problem initially closing his hand all on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Discomfort, Vomiting
Clinical narrative: Severe discomfort; Diarrhea; Not even an hour after injection she started vomiting violently; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for the daughter. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation.  The patient's medical history and concomitant medications were not reported. Not even an hour after injection she started vomiting violently with outcome of unknown. The patient also experienced severe discomfort and diarrhea, all on an unspecified date with outcome of unknown.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electroencephalogram normal, Seizure like phenomena
Clinical narrative: 2mo with seizure like activity after vaccinations approximately 4 hrs later O  fever
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Loss of consciousness, Road traffic accident, Syncope
Clinical narrative: Syncope (drop in blood pressure) Passed out...Occurred while driving resulting in car accident
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Hyperhidrosis, Influenza like illness, Lethargy, Nausea
Clinical narrative: 1. Complete Lethargy 2. DiaRRhea for 3 wks.  3. Nausea 4. Fever / sweats 5. Rash Body Wide 6. Flu like symptoms Stomach is still Nauseated
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: 1. Complete Lethargy 2. DiaRRhea for 3 wks.  3. Nausea 4. Fever / sweats 5. Rash Body Wide 6. Flu like symptoms Stomach is still Nauseated
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Patient presented 24 hours after vaccine with severe myalgias and muscle "burning", but no weakness, fever or other symptoms. Symptoms gradually improved over 2.5 weeks. Treated with Meloxicam 15mg daily, Increased fluids, activity as tolerated.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Hypertension, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: RUNNY NOSE, SLIGHT SORE THROAT TIRED, HIGH BLOOD PRESSURE
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Myalgia, Urticaria
Clinical narrative: Raised erythematous urticaria and myalgia.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Malaise, Pallor, Posture abnormal
Clinical narrative: At 3:12 p.m., immediately after all three of the client's vaccines were administered, the client stated he did not "feel well." His head drooped to his chest and he was pale. His eyes were open. I called for someone to grab a cot and juice. I held the client's shoulders to hold him up in the chair. He was shaking slightly and making a sound with his voice. I stated his name and a few seconds later, he became alert and brought his head up and said "What?" Another RN and I attempted to assist him from the chair to the cot. I asked him if he could use his legs and he slightly moved them. I asked him if he could help the other nurse and I with moving to the cot. He was able to follow direction and bare some weight on his legs during the transfer. The client laid with knees bent on the cot. The client was diaphoretic and pale. He drank sips of juice and was able to answer questions appropriately. He told me what he had for lunch at 11 a.m. He had not eaten anything since then. At 3:15 p.m., his radial pulse was 56 beats per minute. He was able to follow directions and squeeze my hands and tap his feet on the cot when I asked him to. He drank a second juice. After a few minutes, I asked him to sit on the side of the cot. He did so without assistance. The client denied dizziness. I asked him if he remembered what happened and he stated after his last shot, he could see but couldn't hear. After another minute, he was able to stand up on his own without dizziness. I monitored him for another 10 minutes in the clinic room. He was fully alert and oriented when he left the clinic. I advised him and his mom that before his next appointment, he should eat something a few minutes before. They both voiced understanding.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Tremor
Clinical narrative: At 3:12 p.m., immediately after all three of the client's vaccines were administered, the client stated he did not "feel well." His head drooped to his chest and he was pale. His eyes were open. I called for someone to grab a cot and juice. I held the client's shoulders to hold him up in the chair. He was shaking slightly and making a sound with his voice. I stated his name and a few seconds later, he became alert and brought his head up and said "What?" Another RN and I attempted to assist him from the chair to the cot. I asked him if he could use his legs and he slightly moved them. I asked him if he could help the other nurse and I with moving to the cot. He was able to follow direction and bare some weight on his legs during the transfer. The client laid with knees bent on the cot. The client was diaphoretic and pale. He drank sips of juice and was able to answer questions appropriately. He told me what he had for lunch at 11 a.m. He had not eaten anything since then. At 3:15 p.m., his radial pulse was 56 beats per minute. He was able to follow directions and squeeze my hands and tap his feet on the cot when I asked him to. He drank a second juice. After a few minutes, I asked him to sit on the side of the cot. He did so without assistance. The client denied dizziness. I asked him if he remembered what happened and he stated after his last shot, he could see but couldn't hear. After another minute, he was able to stand up on his own without dizziness. I monitored him for another 10 minutes in the clinic room. He was fully alert and oriented when he left the clinic. I advised him and his mom that before his next appointment, he should eat something a few minutes before. They both voiced understanding.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient explained on 10/29/19 that her arm was severely swelled on the evening of 10/26/19, following Shingrix vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: pain at injection site (immediately, continuing for 4 days) fatigue (starting about 13 hours after injection, lasting 48 hours) nausea (about 18 hours after injection, lasting 4 hours) malaise (about 18 hours after, lasting 72 hours) headache (about 18 hours after injection, lasting 72 hours) chills (about 18 hours after injection, lasting about 4 hours)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: pain at injection site (immediately, continuing for 4 days) fatigue (starting about 13 hours after injection, lasting 48 hours) nausea (about 18 hours after injection, lasting 4 hours) malaise (about 18 hours after, lasting 72 hours) headache (about 18 hours after injection, lasting 72 hours) chills (about 18 hours after injection, lasting about 4 hours)
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On the area of Flu injection, warm erythematous area about 7x6 cm diameter. No pus discharge. Able to move arm well.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: patient filled out our questionaire and did not answer yes to any questions. when he was asked if he ever had any reactions to any reactions he said no. pt then fainted after the shot. we laid him on the floor and after a few seconds he regained consciousness. we kept him laying on the floor for a few more minutes until he felt comfortable getting him up, then we helped him to his chair. pt stated to be feeling fine so we let him leave.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Malaise, Oropharyngeal pain, Throat tightness
Clinical narrative: patient complained of generally not feeling well and laid down in the hours after the injection.  When she awoke she had severe chest pain and felt as if the back of her throat was closing and was sore.  She went to emergency room and was admitted for observation. She spent 1.5 days in hospital.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Impaired work ability, Nausea
Clinical narrative: High fever, chills, body aches, headache, stomach ache, nausea. Was not able to work. So far, it has lasted 1 day. Took Aleve to break the fever which helped.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: High fever, chills, body aches, headache, stomach ache, nausea. Was not able to work. So far, it has lasted 1 day. Took Aleve to break the fever which helped.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PER PATIENT CAREGIVER : S WELL AND REDDENING OF THE LEFT ARM THE DAY AFTER VACCINATION.  PROGRESSED DOWN TO THE ELBOW.   RECOMMENDED SHE CONTACT HER DOCTOR
Age: 55.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Chest pain, Headache, Injection site erythema, Pruritus, Pyrexia
Clinical narrative: Patient called on 10/23/19 with complaints of fever and chest pain.  advised to go to the ER.   patient went to EX-press care on 10/26/19 with complaints of rash on torso, R arm, face and L arm, with itchiness.  Also complaining of localized redness at injection site.  Patient then went to the ER on 10/28/19 with complaints of an itchy rash and headache.  Patient noted to have a few macular papular lesions on face, head, neck  and torso, without drainage.  Afebrile
Age: 55.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient called on 10/23/19 with complaints of fever and chest pain.  advised to go to the ER.   patient went to EX-press care on 10/26/19 with complaints of rash on torso, R arm, face and L arm, with itchiness.  Also complaining of localized redness at injection site.  Patient then went to the ER on 10/28/19 with complaints of an itchy rash and headache.  Patient noted to have a few macular papular lesions on face, head, neck  and torso, without drainage.  Afebrile
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: Patient reports nausea, fatigue, weakness, and red/itchy injection site reaction
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Ear congestion, Ear swelling, Feeling abnormal, Hypoaesthesia, Neck pain
Clinical narrative: Patient returned to the clinic site approximately 30 minutes after receiving her flu vaccine. She reported left ear congestion/ numbness. She also reported pain of the left neck and throat. She described the sensation as "numb" and "feeling like Novocain." Lungs clear. Left jaw and ear appear swollen. Vitals were taken Pulse=68, RR=18, BP= 118/84, T=97.9. Patient reports unchanged status for next 20 minutes. Refused emergency medical assistance. Since mobile clinic, spoke with ordering MD (off-site), instructed to administer Benadryl. Benadryl administered L anterior thigh. Vitals re-checked. P=68 BP=108/82. Patient states sorness in throat in neck is a "little less." Per Dr., observe patient for 15 minutes. Cleared pt to return to class/ no need for emergency medical care. Pt reported feeling well after 15 minutes and returned to class. Was asked to return if symptoms re-appeared. Pt did not return.