chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 10-OCT-2015, at a pharmacy, the patient was inoculated with ZOSTAVAX, (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a physician/MD (at an unspecified facility) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was subsequently treated by the same physician/MD for ongoing and worsening outbreaks of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not recovered. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-APR-2010, at a medical center, the patient was inoculated with ZOSTAVAX, (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUN-2015, the patient was treated at the medical center (by an unspecified healthcare professional) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acetaminophen and oxycodone hydrochloride (PERCOCET) and oxycodone and acetaminophen for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-SEP-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 09-NOV-2015, the patient was treated for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed topical creams for the management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 14-OCT-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-DEC-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-DEC-2013, at a pharmacy, the patient was inoculated with ZOSTAVAX, (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2015, the patient was treated at a hospital (by an unspecified healthcare professional) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The female patient was prescribed acyclovir for management of her painful and persistent symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not recovered. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Nervous system disorder, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-DEC-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-DEC-2013, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with nervous system complications. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Irritability, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a pharmacist (patient's mother) on 03-Nov-2017. This case involves a 10-month-old male patient who was vaccinated with a 0.5 ml first single dose of FLUZONE QIV (batch number, expiration date, site of administration were not reported) intramuscularly on 31-Oct-2017. Patient's medical history was not reported. Concomitant medications were not reported. It was also reported that he had not received any other vaccines. On 01-Nov-2017, one day following the vaccination, the patient was irritable. On 02-Nov-2017, two days after the vaccination, he experienced an elevated temperature to 102.8 degree Fahrenheit and broke out in a rash. It was also a case of actual medication error due to overdose Other laboratory investigations was not reported. The patient did not receive any corrective treatment at this time. The outcome of the events was reported as not recovered. Follow-up information received from a pharmacist (patient's mother) in the United States on 28-Dec-2017. This patient was vaccinated with a 0.25 ml first single dose of FLUZONE QIV (Batch number: UT5897JA) intramuscularly in left thigh on 31-Oct-2017. The patient's immunization history included first, second and third doses of PEDIARIX on 17-Feb-2017, 19-Apr-2017 and 20-Jun-2017 respectively. First dose of VAQTA on 20-Dec-2017, first dose of HEPATITIS B VACCINE on 15-Dec-2016, first and second dose of PEDVAXHIB on 17-Feb-2017 and 19-Apr-2017, first and second dose of  FLUZONE IIV4 P-FREE on 31-OCT-2017 and 06-DEC-2017, first dose of MMR II on 20-DEC-2017, first, second, third and fourth doses of PREVENAR 13 on 17-Feb-2017, 19-Apr-2017, 20-Jun-2017 and on 20-Dec-2017 respectively and first and second dose of ROTATEQ on 17-FEB-2017 and 19-APR-2017. The event of medication error (overdose) was removed as the patient received correct dose of flu vaccine. On 03 Nov 2017, one day post following vaccination, mother called office reported fever and rash on arms. He also had runny nose due to possible viral illness. No distress noted. It was unsure if the patient was seen by medical staff. Mom was advised if he worsened she may give DIPHENHYDRAMINE HYDROCHLORIDE (Benadryl). Patient was in care of grandparent at the time. The patient was recovered from the events. He received a second dose of Fluzone 0.25 mL on 06-Dec-2017 without any incident. List of documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site scab
Clinical narrative: Initial unsolicited report received from a consumer on 28-Dec-2017. This case involves an 80-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE in right deltoid via intramuscular route on 03-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, 3 weeks following the vaccination, the patient developed injection site reaction, developed a scab that was elevated. Initial size was 1.5cm, each time the scab falls off, the site is smaller, and currently it is 3mm. There was also redness at the site. Initially the reaction became larger and larger, then became smaller and has not yet healed. The patient's laboratory data and corrective treatment were not reported. At the time of report the patient was not recovered from events. List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Urticaria
Clinical narrative: Local reaction measuring 6 cm x 7 cm, smooth edges urticarial rash covering trunk, face, and extremities. Treatment - BENADRYL didn't help. Mom to monitor - if gets worse Dr. will treat with Prednisone.
Age: 56.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Skin rash and hard knot, swelling and redness at injection site, pain that radiates up arm to shoulder, itchy rash on right forearm. Methylprednisolone 80 mg once, Methylprednisolone 4 mg other, Diphenhydramine 25 mg QID.
Age: 56.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Nodule, Rash pruritic
Clinical narrative: Skin rash and hard knot, swelling and redness at injection site, pain that radiates up arm to shoulder, itchy rash on right forearm. Methylprednisolone 80 mg once, Methylprednisolone 4 mg other, Diphenhydramine 25 mg QID.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT CALLED SAME DAY AFTER GETTING VACCINE COMPLAINING HER ARM WAS IMMOBILIZED. SHE WAS DIRECTED TO GO TO HER DOCTOR IF HER ARM WAS IMMOBILIZED. SHE CALLED THE PHARMACY A FEW DAYS LATER AND SPOKE TO THE PHARMACY MANAGER WHO TOLD HER TO SEE A DOCTOR AGAIN IF HER ARM WAS STILL  PAINFUL AND IMMOBILIZED AND ASKED IF THERE WAS ANYTHING WE COULD DO. SHE AGAIN CALLED THE PHARMACY 1/9/18 TO DESCRIBE THAT SHE HAD GOTTEN SOME MOBILITY BACK BUT SHE THINKS THE INJECTION WAS GIVEN TOO HIGH ON HER ARM.  AFTER SPEAKING WITH THE DOCTOR HE SAID SHE WAS SEEN IN THE OFFICE AND THERE WAS A SMALL BIT OF SWELLING IN HER ARM. HE SAID THE SHOT MAY HAVE BEEN GIVEN A TAD BIT HIGH (ONE FINGER TOO HIGH FOR THE 3 FINGER RULE) BUT THERE WAS NO REASON SHE SHOULD BE IMMOBILIZED. HE SAID THERE WAS NO MECHANISM HE COULD THINK OF THAT WOULD CAUSE A PATIENT TO HAVE AN IMMOBILIZED ARM EVEN IF IT WAS GIVEN A LITTLE BIT HIGHER UP ON THE ARM. THE DOCTOR SAID HE WOULD CALL THE PATIENT AND SEE HER AGAIN AND REFER HER TO A SPECIALIST IF SHE IS STILL HAVING IMMOBILITY PROBLEMS.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in left arm. Has persisted for two months.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Mother called to report swelling/redness in right thigh 1" across, no fever or pain at injection site, no heat, no streaking redness. Developed fever on 1/6/18 of 103.3, responded to Tylenol.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: (I am RIGHT-handed and vaccination was in my LEFT arm). Approximately 48 hrs. post-vaccination I started experiencing pain in back of my neck muscles and high back just below my neck. Within additional 12-24 hrs. I also started experiencing pain in my RIGHT shoulder and right upper arm with referred (?) pain down into my right forearm. This pain (with related weakness) was so severe that I could not lift a water glass, hold a toothbrush or paintbrush with my right hand.  Pain was interfering with my sleep and routine daily activities (such as putting on/off clothing). With treatment, my pain has now improved but I still have significant pain in same affected areas.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Sleep disorder
Clinical narrative: (I am RIGHT-handed and vaccination was in my LEFT arm). Approximately 48 hrs. post-vaccination I started experiencing pain in back of my neck muscles and high back just below my neck. Within additional 12-24 hrs. I also started experiencing pain in my RIGHT shoulder and right upper arm with referred (?) pain down into my right forearm. This pain (with related weakness) was so severe that I could not lift a water glass, hold a toothbrush or paintbrush with my right hand.  Pain was interfering with my sleep and routine daily activities (such as putting on/off clothing). With treatment, my pain has now improved but I still have significant pain in same affected areas.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Lip swelling, Swelling, Swelling face, Urticaria
Clinical narrative: It started with swelling in my cheek that quickly progressed to my lips and face. I went to the ER where it continued to progress to my hands. After the visit to the ER and a shot of epinephrine, DECADRON and VISTARIL, I felt better. I started taking hydroxyzine pamoate and methylprednisolone but by that evening, the condition worsened with welts starting in my hands, arms, then chest, back, head and legs. I went to an urgent care the next day and was given two more drugs to take - ZANTAC (hard to swallow) and Alkron H3 and was told that the reaction would run its course eventually. It started to get better in about 24 hours and then eventually, it went away. It was awful, something I had never experienced.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Angioedema, Blood pressure increased, Dysphagia, Lip swelling, Swelling face
Clinical narrative: It started with swelling in my cheek that quickly progressed to my lips and face. I went to the ER where it continued to progress to my hands. After the visit to the ER and a shot of epinephrine, DECADRON and VISTARIL, I felt better. I started taking hydroxyzine pamoate and methylprednisolone but by that evening, the condition worsened with welts starting in my hands, arms, then chest, back, head and legs. I went to an urgent care the next day and was given two more drugs to take - ZANTAC (hard to swallow) and Alkron H3 and was told that the reaction would run its course eventually. It started to get better in about 24 hours and then eventually, it went away. It was awful, something I had never experienced.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Affective disorder, Injection site induration, Injection site nodule, Pain
Clinical narrative: Mother reported on 1/08/18 that when her child received MMR, Varicella, Hep A, Hep B, PENTACEL, and PREVNAR 13 vaccine she reacted to it with really hard nodules on the injection cite that lasted a few weeks/months. Per mom, patient had a fever she was sore and tender to the touch. Per mom pt was very moody after received vaccines and did not act like her normal self.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Tenderness
Clinical narrative: Mother reported on 1/08/18 that when her child received MMR, Varicella, Hep A, Hep B, PENTACEL, and PREVNAR 13 vaccine she reacted to it with really hard nodules on the injection cite that lasted a few weeks/months. Per mom, patient had a fever she was sore and tender to the touch. Per mom pt was very moody after received vaccines and did not act like her normal self.
Age: 29.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Presyncope
Clinical narrative: Patient had a near syncopal episode about 5 minutes after receiving the vaccines. Patient was able to lay down to avoid completely passing out. She had no previous reactions to vaccines in the past.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Lichenoid keratosis, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: My skin surfaces began to burn and itch tremendously. I started to have red skin dots all over my body. The itching and burning sensation increased rapidly and could only be relieved some by cool shower. The small red dots began to peel around the edges in about two days. I was sent to a dermatologist who prescribed high dose Cortisone cream to be put all over my areas of skin. Then she decided to do a skin biopsy and it call me back as a Lichenoid skin outbreak. It took two and one half  months for my skin to begin to look normalizing. I continued the Cortisone treatment for another month until the skin returned to normal.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation, Skin exfoliation
Clinical narrative: My skin surfaces began to burn and itch tremendously. I started to have red skin dots all over my body. The itching and burning sensation increased rapidly and could only be relieved some by cool shower. The small red dots began to peel around the edges in about two days. I was sent to a dermatologist who prescribed high dose Cortisone cream to be put all over my areas of skin. Then she decided to do a skin biopsy and it call me back as a Lichenoid skin outbreak. It took two and one half  months for my skin to begin to look normalizing. I continued the Cortisone treatment for another month until the skin returned to normal.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hyperhidrosis, Pyrexia, Rhinorrhoea
Clinical narrative: I developed a severe headache that lasted all night and until 3 pm the next day, dizziness, runny nose, and sweaty and feverish.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Swelling of the deltoid and bruising. Itching, spreading redness, tender to the touch.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from the authors in a letter to the editor and refers to retrospective epidemiologic assessment involving 3811 employees. The authors found a nonlinear decline in mumps seropositivity over time, with a sharp decrease 13 years after the most recent measlesmumpsrubella (MMR) vaccine dose on the basis of antibody titers obtained at the outset of employee training with the use of the BioPlex 2200 MMRV IgG multiplex flow immunoassay (Bio-Rad). Seropositivity fell below the estimated herd-immunity threshold among those last vaccinated at least 16 years earlier. Since recent mumps outbreaks have occurred in populations that had been vaccinated as children, the findings raise concern about the need for routine administration of MMR vaccine in young adults entering congregated settings, such as colleges and employee training. This case refers to 45 employees of unspecified ages and genders. The patient's concurrent conditions, medical history or concomitant medications were not reported. On unspecified dates from 1998 to 2014, 73 patients were vaccinated with two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, frequency, lot number and expiration date were not reported), from which  6 patients developed mumps on unspecified dates. 7 patients received three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). On unspecified dates from 2015 to 2016,  2 patients were vaccinated with one dose  of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, frequency, lot number and expiration date were not reported). Both patients developed mumps on unspecified dates; 18 patients received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) from which 10 developed mumps on unspecified dates; 14 patients received three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) from which 2 patients developed mumps on unspecified dates. On unspecified date in 2017, 2 patients were vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) as prophylaxis (dose, frequency, lot number and expiration date were not reported); 3 patients received three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). And on an unspecified date, 1 patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). The outcome of the event mumps was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Genital herpes zoster, Herpes zoster, Nodule, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-OCT-2011 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient have serious internal complications and to contract a persistent strain of herpes zoster. Shortly after being vaccinated the patient was hospitalized for kidney issues at which time she was evaluated by a team of Internal Medicine specialist who deducted that her kidneys were spotted with unusual nodules and vesicles, which was likely a complication of the vaccine or an internal outbreak of zoster. The patient continued to experience health issues and zoster complications. On or about 01-SEP-2017 the patient was treated by a physician for shingles outbreaks that were diagnosed as severe herpes zoster that had spread into her genitals, resulting in excruciating pain and impossibility of topical treatment or relief. The patient has been prescribed VALTREX and pain medication for management of her ongoing and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Renal disorder, Vaccination complication
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-OCT-2011 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient have serious internal complications and to contract a persistent strain of herpes zoster. Shortly after being vaccinated the patient was hospitalized for kidney issues at which time she was evaluated by a team of Internal Medicine specialist who deducted that her kidneys were spotted with unusual nodules and vesicles, which was likely a complication of the vaccine or an internal outbreak of zoster. The patient continued to experience health issues and zoster complications. On or about 01-SEP-2017 the patient was treated by a physician for shingles outbreaks that were diagnosed as severe herpes zoster that had spread into her genitals, resulting in excruciating pain and impossibility of topical treatment or relief. The patient has been prescribed VALTREX and pain medication for management of her ongoing and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2013, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 09-MAY-2016, the patient was treated by a physician for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin for the management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 04-MAR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-FEB-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as sever herpes zoster or shingles with complications. The patient was prescribed valacyclovir, acyclovir and tramadol for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous during March 2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-OCT-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 24-FEB-2016, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of severe herpes zoster. On or about 10-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed tramadol for management of her painful symptoms. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-NOV-2014, the patient was inoculated with ZOSTAVAX at a public health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2017, the patient was treated by a physician an a community healthcare center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. He was prescribed acyclovir and acetaminophen (+) hydrocodone (NORCO) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient had fever of 101 and then 102 later that evening. He also complained of injection site pain. Wife administered acetaminophen and ibuprofen alternating every four hours.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Raised splotchy red rash all over body which started about 2.5 weeks after MMR injection given. No difficulty breathing or other sx.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Pt's son stated that his mother's arm is swollen.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: 34 weeks pregnant first time, Due date 2/18/2018. 1/3/2018 - Received TDAP vaccination during third trimester. 1/4/2018 - Slight raised swelling by the evening, sore and tenderness in arm Overnight - Body Aches, muscle pain, trouble sleeping. 1/5/2018 - Unable to work, flu like symptoms, extreme tiredness, body aches, upper right arm swollen and HOT (width of tennis ball). 1/6/2018 - Out at a store, felt like I may faint, shortness of breath. Went home, headache followed by nausea, fatigue, upper right arm swollen and HOT (width of softball). 1/7/2018 - Muscle/arm still sore, felt physically better but by late afternoon fatigue kicked in and felt "off". Upper right arm swollen and HOT (size of my hand). 1/8/2018 - Feeling physically better, still swollen and HOT. 1/9/2018 - OBGYN appt, did not like how swollen the site was and asked me to submit the symptoms to VAERS.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Influenza like illness, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: 34 weeks pregnant first time, Due date 2/18/2018. 1/3/2018 - Received TDAP vaccination during third trimester. 1/4/2018 - Slight raised swelling by the evening, sore and tenderness in arm Overnight - Body Aches, muscle pain, trouble sleeping. 1/5/2018 - Unable to work, flu like symptoms, extreme tiredness, body aches, upper right arm swollen and HOT (width of tennis ball). 1/6/2018 - Out at a store, felt like I may faint, shortness of breath. Went home, headache followed by nausea, fatigue, upper right arm swollen and HOT (width of softball). 1/7/2018 - Muscle/arm still sore, felt physically better but by late afternoon fatigue kicked in and felt "off". Upper right arm swollen and HOT (size of my hand). 1/8/2018 - Feeling physically better, still swollen and HOT. 1/9/2018 - OBGYN appt, did not like how swollen the site was and asked me to submit the symptoms to VAERS.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Swelling
Clinical narrative: 34 weeks pregnant first time, Due date 2/18/2018. 1/3/2018 - Received TDAP vaccination during third trimester. 1/4/2018 - Slight raised swelling by the evening, sore and tenderness in arm Overnight - Body Aches, muscle pain, trouble sleeping. 1/5/2018 - Unable to work, flu like symptoms, extreme tiredness, body aches, upper right arm swollen and HOT (width of tennis ball). 1/6/2018 - Out at a store, felt like I may faint, shortness of breath. Went home, headache followed by nausea, fatigue, upper right arm swollen and HOT (width of softball). 1/7/2018 - Muscle/arm still sore, felt physically better but by late afternoon fatigue kicked in and felt "off". Upper right arm swollen and HOT (size of my hand). 1/8/2018 - Feeling physically better, still swollen and HOT. 1/9/2018 - OBGYN appt, did not like how swollen the site was and asked me to submit the symptoms to VAERS.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: 34 weeks pregnant first time, Due date 2/18/2018. 1/3/2018 - Received TDAP vaccination during third trimester. 1/4/2018 - Slight raised swelling by the evening, sore and tenderness in arm Overnight - Body Aches, muscle pain, trouble sleeping. 1/5/2018 - Unable to work, flu like symptoms, extreme tiredness, body aches, upper right arm swollen and HOT (width of tennis ball). 1/6/2018 - Out at a store, felt like I may faint, shortness of breath. Went home, headache followed by nausea, fatigue, upper right arm swollen and HOT (width of softball). 1/7/2018 - Muscle/arm still sore, felt physically better but by late afternoon fatigue kicked in and felt "off". Upper right arm swollen and HOT (size of my hand). 1/8/2018 - Feeling physically better, still swollen and HOT. 1/9/2018 - OBGYN appt, did not like how swollen the site was and asked me to submit the symptoms to VAERS.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: As per pt, she states that the next morning she had a large welt at injection sight that itched and hives to the face.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PPV
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Eye swelling, Insomnia
Clinical narrative: On 6/30/17, the day after receiving the vaccines; my baby developed extremely blood shot eyes. The whites of her eyes were red and swollen. She randomly would have a fever for the following week after injections. Also had moments where she was completely inconsolable. Screaming and crying not eating well and barely napping but also lethargic and not acting herself. Exactly 7 days after injections on 7/06/17 she woke up with a rash all over her face and neck. We took her to the Peds office and her Pediatrician was out of the office so we saw a different doctor, and she said it was likely a reaction to the MMR vaccine she had the previous week. Keep an eye on her and as long as she didn't get a high fever she would be fine. I believe it took about 3 days for the rash to go away and never spread past her neck.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PPV
Symptoms: Lethargy, Ocular hyperaemia, Pyrexia, Rash, Screaming
Clinical narrative: On 6/30/17, the day after receiving the vaccines; my baby developed extremely blood shot eyes. The whites of her eyes were red and swollen. She randomly would have a fever for the following week after injections. Also had moments where she was completely inconsolable. Screaming and crying not eating well and barely napping but also lethargic and not acting herself. Exactly 7 days after injections on 7/06/17 she woke up with a rash all over her face and neck. We took her to the Peds office and her Pediatrician was out of the office so we saw a different doctor, and she said it was likely a reaction to the MMR vaccine she had the previous week. Keep an eye on her and as long as she didn't get a high fever she would be fine. I believe it took about 3 days for the rash to go away and never spread past her neck.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PPV
Symptoms: Vaccination complication
Clinical narrative: On 6/30/17, the day after receiving the vaccines; my baby developed extremely blood shot eyes. The whites of her eyes were red and swollen. She randomly would have a fever for the following week after injections. Also had moments where she was completely inconsolable. Screaming and crying not eating well and barely napping but also lethargic and not acting herself. Exactly 7 days after injections on 7/06/17 she woke up with a rash all over her face and neck. We took her to the Peds office and her Pediatrician was out of the office so we saw a different doctor, and she said it was likely a reaction to the MMR vaccine she had the previous week. Keep an eye on her and as long as she didn't get a high fever she would be fine. I believe it took about 3 days for the rash to go away and never spread past her neck.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Reports the following day arm at vaccine site (L arm)  was red, swollen , warm to touch, and a low grad fever for 2days.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Injected limb mobility decreased, Injection site swelling, Pain
Clinical narrative: SIGNIFICANT PAIN AND DISCOMFORT - OUT OF A SCALE OF 1 TO 10 IT'S A 9. SWELLING - LEFT UPPER ARM TWICE THE SIZE OF MY RIGHT ARM. UNABLE TO LIFT ARM UP MORE THAN A FEW INCHES. I HAVE TAKEN 6 ADVIL OVER 12 HOURS AND APPLIED ICE PACKS FOR PAIN & SWELLING. ARM FEELS BETTER USING ICE PACK AND TAKING ADVIL.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, patient unable to fully lift arm.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Bilevel positive airway pressure, Biopsy lung, Influenza virus test positive, Intensive care, Metapneumovirus infection
Clinical narrative: Hospitalized, flu positive, now needs lung transplant, never got better. Was in ICU with metapneumovirus. Turned into possible bronchitis obliterans.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reaction consisted of swelling, pain and redness at the vaccine site.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Hives over hands, arms, legs, abdomen, and back. Ears became red, hot and very itchy. Hands and legs were also very itchy.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Discomfort, Feeling cold, Malaise, Nervousness
Clinical narrative: Post vaccination approximately 15 minutes, patient and caretaker described patient's condition as being uncomfortable or not feeling well when asked. Patient appeared nervous, clammy, and cold. Patient was able to breathe and respond when spoken to. Patient did not lose consciousness. Patient condition remained the same and there was no mention of condition worsening. EMT was called immediately. Upon arrival patient walked away with EMT workers.
Age: 5.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Aspiration joint, Bacterial test negative, Blood culture, Borrelia test negative, C-reactive protein increased
Clinical narrative: Left thigh became swollen and painful from groin to mid-calf. Left knee became very swollen and painful - child unable to flex knee. Child became febrile about 36 hrs after vaccines given. Left knee was aspirated and child went to OR for knee irrigation. All joint fluid cultures were negative for bacteria, fungal CX pdg. Child had 48 hrs of IV ceftriaxone and clindamycin. Child seen 1/3/18 for F/U exam. She is improving but still has pain in Left knee and swelling of knee joint. She is able to walk with help of her parents or a walker.
Age: 5.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fungal test, Injection site joint pain, Injection site joint swelling, Injection site movement impairment, Injection site pain
Clinical narrative: Left thigh became swollen and painful from groin to mid-calf. Left knee became very swollen and painful - child unable to flex knee. Child became febrile about 36 hrs after vaccines given. Left knee was aspirated and child went to OR for knee irrigation. All joint fluid cultures were negative for bacteria, fungal CX pdg. Child had 48 hrs of IV ceftriaxone and clindamycin. Child seen 1/3/18 for F/U exam. She is improving but still has pain in Left knee and swelling of knee joint. She is able to walk with help of her parents or a walker.
Age: 5.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Joint irrigation, Myositis, Nuclear magnetic resonance imaging abnormal, Synovial fluid white blood cells positive
Clinical narrative: Left thigh became swollen and painful from groin to mid-calf. Left knee became very swollen and painful - child unable to flex knee. Child became febrile about 36 hrs after vaccines given. Left knee was aspirated and child went to OR for knee irrigation. All joint fluid cultures were negative for bacteria, fungal CX pdg. Child had 48 hrs of IV ceftriaxone and clindamycin. Child seen 1/3/18 for F/U exam. She is improving but still has pain in Left knee and swelling of knee joint. She is able to walk with help of her parents or a walker.
Age: 5.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Synovitis, Walking aid user, White blood cell count increased
Clinical narrative: Left thigh became swollen and painful from groin to mid-calf. Left knee became very swollen and painful - child unable to flex knee. Child became febrile about 36 hrs after vaccines given. Left knee was aspirated and child went to OR for knee irrigation. All joint fluid cultures were negative for bacteria, fungal CX pdg. Child had 48 hrs of IV ceftriaxone and clindamycin. Child seen 1/3/18 for F/U exam. She is improving but still has pain in Left knee and swelling of knee joint. She is able to walk with help of her parents or a walker.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Swelling over the left side of the upper neck with some diffuse erythema seen. Enlarged lymph node in the left upper cervical chain around 3.5 cms x 1.5 cms felt with minimal discomfort.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Some mild redness around the vaccination site immediately after vaccination. Slowly the (R) arm was swollen by about a inch all the way from the shoulder down to hand.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, itching, warm to touch at site of injection.
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: This initial non-serious spontaneous case, was received other non-health professional on 09-Aug-2017, via health authority (VAERS ID: 595844), concerning an adult male patient of unspecified age. On an unspecified date, the patient received INN Flu Vaccine (anatomical location, route of administration, dose, batch number, trade name, manufacturer: not reported). On an unspecified date, at 3 weeks about vaccination, the patient experienced vertigo, light-headedness and fatigue. The outcome of the events was not reported. The health authority considered the report as non-serious. Significant case correction received on 24-Aug-2017: Company causality for the events vertigo, light headedness and fatigue was changed from unassessable to related.