chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site warmth, Skin warm, Urticaria
Clinical narrative: 9/29/17 - Received flu vaccine, not welts near injection site then noticed more welts and warm to touch on opposite are of injection site. Approx 5 hours after no DIB no CP.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Started with itching 4-5 hours post injection. Denies hives or rash. Itching to palms, scalp, neck and waist. Takes BENADRYL at home it goes away but by morning itching returns.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Rash around injection site and pain in arm from shoulder to hand the day after. Took ibuprofen and felt better.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Gait inability, Pain in extremity
Clinical narrative: Shopping in local store when I experienced severe back and leg pain. I could no longer walk so returned home. Went to bed at 8:00 PM. The following day I still had mild pain but it finally subsided later in the day (11-10-16). I did report incident to doctor's office.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Expired product administered
Clinical narrative: Nurse gave expired vaccine. BEXSERO expired 9/30/17 gave it 10/2/17 - called manufacturer - got guidelines and info. No action required.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Nodule
Clinical narrative: Large knot and bruise all the way down to elbow.
Age: 85.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Back pain, Neck pain
Clinical narrative: Neck and back hurts. Started 24 hrs after shot.
Age: 9.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Inadvertently gave DTaP at age of 9 years.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient presented to doctor's office with redness and swelling of left arm. Diagnosed as cellulitis, and prescribed cephalexin 500mg QID for 7 days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: 4 hours after receiving flu vaccine, she noticed pain and swelling to the site, pain radiated down her arm and fingers tingled, 24hr later - area still swollen, no redness, warm to touch. She applied ice to site.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warm to touch no pain (or) hurt per Grandmother. Told grandmother to give TYLENOL/MOTRIN pain plus BENADRYL for redness. Next day all clear per grandmother.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient reported chills, fever of 101 degrees, whelp at site of injection. Red, hot, swollen arm 4-5 inches down from site of injection.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient reported chills, fever of 101 degrees, whelp at site of injection. Red, hot, swollen arm 4-5 inches down from site of injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash macular, Rhinitis
Clinical narrative: Red blotchy raised rash (L) thigh. Fever x2 days. Heavy rhinitis.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Eye pruritus, Fatigue, Injection site pain, Injection site rash, Insomnia
Clinical narrative: Patient called on 09/27/17 stating that she was itchy all over, body aches, fatigue, site of injection was sore. There is rash on site of injection. Was to take BENADRYL 25 mg four times a day. Called back on 09/28/17, stating that couldn't sleep, itchy all over. Started to take ALLEGRA 180 mg one tablet once a day, ranitidine 150 mg one tablet twice. Patient was then seen on 10/09/17, rash had spread to her another arm, per Dr. patient is to use cool compress for 10-15 minutes every few hours as needed, restart BENADRYL 25 mg one capsule every day, cetirizine 10 mg one tablet by mouth daily. Was given referral to allergies as well.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Rash
Clinical narrative: Patient called on 09/27/17 stating that she was itchy all over, body aches, fatigue, site of injection was sore. There is rash on site of injection. Was to take BENADRYL 25 mg four times a day. Called back on 09/28/17, stating that couldn't sleep, itchy all over. Started to take ALLEGRA 180 mg one tablet once a day, ranitidine 150 mg one tablet twice. Patient was then seen on 10/09/17, rash had spread to her another arm, per Dr. patient is to use cool compress for 10-15 minutes every few hours as needed, restart BENADRYL 25 mg one capsule every day, cetirizine 10 mg one tablet by mouth daily. Was given referral to allergies as well.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Dark, itchy red patch developed on upper arm, below injection site on 9/22/17. Patient returned to pharmacy on 9/24/17 at 1 pm. Area was 8 cm x 11 cm and had faded to pink in color. Patient took Ibuprofen on 9/22 and 9/23, and Meclizine 9/24 in arm.
Age: 54.0
Sex: U
Vaccine: FLU4
Symptoms: Altered state of consciousness, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: 3 1/2 - 4 hrs after shot, felt really dizzy - almost like passing out. Turned pale and had short bout of excessive sweating.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported chills, fever of 100 degrees, lump at site of injection, red, hot, swollen arm 4-5 inches down from site of injection.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient reported chills, fever of 100 degrees, lump at site of injection, red, hot, swollen arm 4-5 inches down from site of injection.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate injection site swelling after needle removal. Administered BENADRYL 50 mg x 1 dose.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: Pt presented 10/2/17 with rash on same arm as injection. Rash was red and warm. Pt's PCP diagnosed as cellulitis.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient is complaining of shoulder pain radiating down her arm. She claims pharmacist had given the shot too high. It's been about 2 months and she thinks it is due to the flu shot. Sore arm.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Neck mass, Neck pain, Rash, Rash erythematous, Skin warm
Clinical narrative: Developed a hot, red rash on left side of neck that spread and go worse since vaccine and now has a lump on neck too and painful.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pain in extremity, Skin warm, Swelling
Clinical narrative: Soreness from mild deltoid to elbow - feels flush (face) - red and hot to touch - swollen - patient has had similar but less severe reaction to previous flu shot.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient complains of limited range of motion of her left arm. She has to use her right hand to open her car door.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Vomiting
Clinical narrative: Patient got flu quad 0.5 ml at 0911 AM, left office. Started getting hives at 1030 AM. No respiratory distress. Mom gave BENADRYL at 11 AM vomited at 11:30. Took nap, hives went away.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Sore - red swollen areas at injection site.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Body temperature increased, Lymphadenopathy, Oropharyngeal pain, Streptococcus test negative
Clinical narrative: Patient received the flu vaccine at school - shortly after getting the vaccine the patient complained of sore throat and stomachache - temp. noted by parent of 102 - unknown if symptoms are related to the flu vaccine.
Age: 86.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited case received from a nurse on 19 Sep 2017. This case involves 86-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE HD (Batch number: UI840AC, expiry date, dose in series were not reported) intramuscularly in right deltoid on 18 Sep 2017. Patient medical history and concomitant medications were not reported. On an unknown date, after the vaccination, the patient returned with his wife today for her appointment and mentioned how red his arm was. He has swelling that is 5 inches by 6 inches it's red and warm to the touch. They are having their available provider see him today to recommend a plan of action. Patient relevant lab tests and corrective treatment were not reported. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial unsolicited case received from a nurse on 19 Sep 2017. This case involves 86-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE HD (Batch number: UI840AC, expiry date, dose in series were not reported) intramuscularly in right deltoid on 18 Sep 2017. Patient medical history and concomitant medications were not reported. On an unknown date, after the vaccination, the patient returned with his wife today for her appointment and mentioned how red his arm was. He has swelling that is 5 inches by 6 inches it's red and warm to the touch. They are having their available provider see him today to recommend a plan of action. Patient relevant lab tests and corrective treatment were not reported. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a 74-year-old female patient. The patient's concurrent conditions, concomitant medications and pertinent medical history were not provided. The patient had no drug reactions or allergies. On 04-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 pre-filled syringe, lot # M043987 with expiration date on 30-JUN-2018, in the left arm (dose and route of administration were not reported), for prevention of pneumonia. The reporter confirmed PNEUMOVAX 23 was properly stored prior to the administration of the vaccine. On the same day, the patient was also vaccinated with a high dose of FLUZONE in the left arm, lot # UI848AA with expiration date on 18-APR-2018 (exact dose and route of administration were not reported). On 05-OCT-2017, the patient experienced redness and swelling at the injection site in her left arm. On the same day, the patient sought medical attention by a primary care physician and was prescribed minocycline for possible cellulitis in the left arm. The outcome of the events was not reported. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a 74-year-old female patient. The patient's concurrent conditions, concomitant medications and pertinent medical history were not provided. The patient had no drug reactions or allergies. On 04-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 pre-filled syringe, lot # M043987 with expiration date on 30-JUN-2018, in the left arm (dose and route of administration were not reported), for prevention of pneumonia. The reporter confirmed PNEUMOVAX 23 was properly stored prior to the administration of the vaccine. On the same day, the patient was also vaccinated with a high dose of FLUZONE in the left arm, lot # UI848AA with expiration date on 18-APR-2018 (exact dose and route of administration were not reported). On 05-OCT-2017, the patient experienced redness and swelling at the injection site in her left arm. On the same day, the patient sought medical attention by a primary care physician and was prescribed minocycline for possible cellulitis in the left arm. The outcome of the events was not reported. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Back disorder, Back pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: High fever 101.8 possibly higher. Severe back pain. Muscle aches more severe than any shot she's had. Extreme swelling at injection site. Never happened before. Back issue most alarming.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, headache, fever, chills, achy, nausea.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Sore throat, headache, fever, chills, achy, nausea.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: The patient had some numbness and tingling in the shoulder and redness in the area of the vaccine. The doctor put the patient on Xyzal for the reaction.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported a headache on the same day of injection about 2 hours later. Next morning, she has a 3-4 cm red circle that is warm to touch around her injection site. She complains of extreme soreness on the area.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 8 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates in 2017 (reported as beginning sometime in May 2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M037770, expiration date: 01-JUN-2019 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 31 degrees Fahrenheit or colder for 1027 hours and 32-35 degrees Fahrenheit for 587 hours. There were no symptoms reported in any of the patients. Data logger was not involved in recording the excursion details. Previous temperature excursion was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006071: US-009507513-1709USA009874: US-009507513-1709USA009815: US-009507513-1709USA009893.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a 12 month old male patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 05-SEP-2017, the patient was inadvertently vaccinated with RECOMBIVAX HB 4th dose, lot # M042322 with an expiration date 21-FEB-2019, intramuscular in the right arm instead of a dose of VAQTA for prophylaxis. Concomitant therapies included M-M-R II and VARIVAX administered at the same office visit. According to the reporter, "the nurse thought she grabbed VAQTA and it was not until after the dose of RECOMBIVAX HB was administered she realized she grabbed the wrong vial". On an unknown date, the nurse had contacted the patient's mother, however the mother did not provide any information in regard to whether or not the patient had any adverse reactions.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Food intolerance, Vomiting projectile
Clinical narrative: This spontaneous report as received from a consumer (a patient's mother) refers to her female child of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II (lot #, expiration date, dose and route of administration were not provided). The patient was 15-18 months old when was vaccinated. On an unknown date, after getting the vaccine, the patient became intolerant to avocado and would projectile vomit it whenever she ate it. The outcome of food (avocado) intolerance was reported as recovered on an unknown date . The relatedness between the event and vaccination with M-M-R II was not defined by reporter.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information has been received from a pharmacist, referring to a currently 39 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates (reported as "in the past"), the patient received two doses of M-M-R II (strength, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the pharmacist stated that the patient had "titers drawn" (recently) due to "his place of employment required it" and the result was that "the titers came back as negative for measles". The outcome of the "titers came back as negative" was unknown and the causality assessment between the event and the vaccination with M-M-R II was not provided by reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62-year-old male patient with none pertinent medical history, concomitant medication and none drug reactions or allergies. On 15-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, lot number L031273 with expiration date 19-NOV-2016 (dose and anatomical location were not reported) for zoster vaccination. On approximately 29-MAR-2016 (reported as about 2 weeks after the ZOSTAVAX injection), the patient complained of joint pain, all over and had worsened over the 3 years. The patient sought medical attention with a pain specialist and no treatment was given for the event. None laboratory diagnostics were performed. At the time of the report, the patient did not recovered from the arthralgia. The relatedness between the event and therapy with ZOSTAVAX was not reported.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, referring to a 79 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On 25-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 on an unspecified arm (strength, dose, frequency, dose number, administration route, lot number and expiration date were not reported), to prevent pneumonia. On 26-SEP-2017, the patient received other dose of PNEUMOVAX 23 (strength, dose, frequency, dose number, administration route, lot number and expiration date were not reported). Concomitant therapies included blood pressure and anxiety medications. On 26-SEP-2017, the patient developed redness and inflammatory response on the same arm as injection site from elbow to shoulder. Lab diagnostics or studies were not performed and the patient did not seek medical attention. The outcome of injection site erythema and injection site inflammation was reported as resolving. The reporter causality assessment between the aforementioned events and PNEUMOVAX 23 was not reported.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 73-year-old female patient with no drug reactions or allergies and unknown pertinent medical history. The patient's concomitant therapies included ibandronate sodium (BONIVA), pantoprazole sodium (PROTONIX), acetaminophen (TYLENOL) and ibuprofen(MOTRIN). On 26-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 in her left arm, lot number N000463 with expiration date 19-OCT-2018 (route and dose were not reported) as the patient was on age to receive the vaccine. On 26-SEP-2017, the patient developed swelling of left arm "up to her armpit and a red streak under her left armpit" (peripheral swelling and erythema). The patient began to take unspecified doses of acetaminophen (TYLENOL) and ibuprofen (MOTRIN) as treatment. No laboratory diagnostics were performed. At the time of the report, the outcome of the peripheral swelling and erythema was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse referring to a 70 year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-SEP-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N010105 with expiration date 15-NOV-2018, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. It was stated that the temperature was 32 to 30 Fahrenheit degrees for 15 minutes. The call was made because a data logger. No previous temperature excursion was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA005003:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 26-SEP-2017, the patient was vaccinated with VARIVAX lot # N019127 with expiration date 22-JUN-2019 (strength, dose, frequency, route of administration were not provided) for prophylaxis. The sterile diluent (unknown lot and unknown expiration date) use for reconstitution did not undergo a temperature excursion. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of -9 degrees Celsius to 8 degrees Celsius for 1 hour/53 minutes. Previous excursions included -14 degrees Celsius to -10 degrees Celsius for 4 hours/45 minutes and -9 degrees Celsius to 8 degrees Celsius for 1 hour/44 minutes. Data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 27-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N018273 with expiration date 17-JUN-2019 (dose, route and anatomical location were not reported). The vaccine was exposed at temperature of 1 C (Celsius) during 10 hours. There was previous temperature excursion and no digital data logger was filled. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 27-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N009777, expiration date: 04-MAR-2018 (frequency and route of administration were unspecified) for prophylaxis diluted with sterile diluent (manufacturer unknown) which did not undergo a temperature excursion. It was unknown if the patient experienced any adverse event. The ZOSTAVAX vaccine was exposed to 15 to 46 Fahrenheit degrees for a time frame of 45 minutes and it was found because of a digital data logger. There was a previous excursion to 6 to 14 Fahrenheit degrees for 1 hour and 45 minutes.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (lot#, frequency, and route of administration were unspecified) for prophylaxis, following a temperature excursion of 24 Fahrenheit degrees for 1 hour and 45 minutes which was found because of a digital data logger (there were no previous excursions). No adverse effects were reported.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Registered Nurse, referring to a 63 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 02-OCT-2017 (also reported as "within past month"), the patient received an expired dose of ZOSTAVAX lot # M032360, with expiration date on 17-AUG-2017 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Central venous catheterisation, Decreased immune responsiveness, Herpes zoster, Pain
Clinical narrative: Information had been received on 06-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 28-OCT-2013 at a family physicians office, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). 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-MAR-2016, patient was admitted to a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms and complications. The patient remained in the hospital until 06-APR-2016 for treatment of zoster and complications attributable to shingles. Upon being discharged, patient was evaluated by a nurse practitioner who noted that patient had received inpatient medical care for her extensive blistering rash across her body, which was diagnosed as severe herpes zoster in two dermatomes. Patient was sent home with a PICC line which administered antiviral medications until it was removed on or about 08-APR-2016. Patient was also diagnosed with post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to zoster infections (onset date not reported). Patient has been prescribed LYRICA, methotrexate and acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, severe herpes zoster in two dermatomes requiring a PICC line/complications attributable to shingles was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash generalised, Rash vesicular
Clinical narrative: Information had been received on 06-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 28-OCT-2013 at a family physicians office, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). 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-MAR-2016, patient was admitted to a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms and complications. The patient remained in the hospital until 06-APR-2016 for treatment of zoster and complications attributable to shingles. Upon being discharged, patient was evaluated by a nurse practitioner who noted that patient had received inpatient medical care for her extensive blistering rash across her body, which was diagnosed as severe herpes zoster in two dermatomes. Patient was sent home with a PICC line which administered antiviral medications until it was removed on or about 08-APR-2016. Patient was also diagnosed with post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to zoster infections (onset date not reported). Patient has been prescribed LYRICA, methotrexate and acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, severe herpes zoster in two dermatomes requiring a PICC line/complications attributable to shingles was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about  06-OCT-2009 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 06-JUN-2016, the patient was treated by a physician assistant at the emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient sought subsequent treatment from the physician for complications and ocular interference of her herpes zoster infections that spread to the eye. The patient was prescribed Acyclovir, Clindamycin and hydrocodone-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, 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 on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 18-NOV-2014 at the 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-OCT-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir (ZORIVAX), and gabapentin 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-OCT-2017 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. The female patient was inoculated with ZOSTAVAX on or about 01-NOV-2011, and again on 26-OCT-2015 at the pharmacy 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). Despite being inoculated twice over the span of four year, the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-SEP-2016, the patient was treated at a medical center 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 valacyclovir (VALTREX) for management of her 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. The outcome of the events was not resolved. 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 on 06-OCT-2017 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-2008, at a physician's office, the patient was inoculated with ZOSTAVAX 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 (no date reported), the patient was treated at a health center/facility 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 valacyclovir (VALTREX) for management of her 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. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death, Leukaemia
Clinical narrative: This spontaneous report was received from a physician via an online article, referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated by her mother who was a nurse, with GARDASIL (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The article reported that the girl on an unspecified date developed leukemia and died. I was unknown if an autopsy was done to the patient. The reported did not mention the causality assessment between the events of leukemia and death with GARDASIL.  Upon internal review, leukemia  and death were determined to be medically significant.; Sender's Comments:  US-009507513-1710USA004070:
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Sxs: Injection Site had edema and erythema present. Swelling was about an inch in diameter. Monitored Pt for about 20 - 30 minutes and the swelling and erythema started to go down. Instructed patient that if they had any other symptoms or if swelling came back or got worse to contact employee for instruction. If started experiencing shortness of breath, instructed to call 911.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: CELLULITIS.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Pharyngeal erythema, Urticaria
Clinical narrative: Patient developed 3 hives on her forehead, which is considered a severe allergic reaction after vaccination. She also developed a red throat that wasn't present before the vaccination.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed 3 hives on her forehead, which is considered a severe allergic reaction after vaccination. She also developed a red throat that wasn't present before the vaccination.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Cough, Coxsackie viral infection, Pyrexia, Rash generalised
Clinical narrative: Patient received the MMR shot (first dose) on Monday September 18th. 4 days later, on Friday September 22nd he developed a rash/hives all over his body. I initially thought it was a reaction to a food that contains eggs and gave him Benadryl; however, the rash wasn't getting any better. On Saturday (09/23/17) around 5 pm pt had high fever 103.7 and after a consultation with his pediatrician over the phone, we went to the closest emergency room. There, they did a swab test for strep and it was positive so they said he has strep and scarlet fever and prescribed amoxicillin for 10 days. By the next day the rash has gotten much better but the fever continued being high.  On Tuesday (09/26/17) we went back to the ER due to high fever. This time the dr said it looks more like coxsockie virus than strep and that we should just let it run it's course. On Thursday (09/28/17) we went back to his pediatrician's office and after examining pt she sent us back to the ER for some lab work because she suspected kawasaki disease. At the ER they did some blood work and urine tests and all results were within normal range so they ruled out Kawasaki disease and sent us back home. The added an additional antibiotic just in case and said if fever continues for 2 more days we should go back to ER for additional labs. Patient's last fever was on Friday (09/29/17) in the morning and the fever went down after he took motrin. The next day, Saturday 09/30/17 he developed a huge rash all over his body. We took him back to his pediatrician's office on Sunday 10/01/17 and she said it looks like fifth disease. He had the rash until Thursday 10/05/17 in addition to peeling skin on his hands and feet. It appears as if pt cough 4-5 contagious viruses although he hasn't been in daycare or any other place where he could have caught these viruses. Neither his 4 years old sister nor my husband and I caught any of these contagious viruses which just proves he didn't actually have them. What he had was a reaction to the MMR shot and his body was fighting the weakened live viruses that were injected in him.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Scarlet fever, Skin exfoliation, Streptococcus test positive, Urine analysis normal, Urticaria
Clinical narrative: Patient received the MMR shot (first dose) on Monday September 18th. 4 days later, on Friday September 22nd he developed a rash/hives all over his body. I initially thought it was a reaction to a food that contains eggs and gave him Benadryl; however, the rash wasn't getting any better. On Saturday (09/23/17) around 5 pm pt had high fever 103.7 and after a consultation with his pediatrician over the phone, we went to the closest emergency room. There, they did a swab test for strep and it was positive so they said he has strep and scarlet fever and prescribed amoxicillin for 10 days. By the next day the rash has gotten much better but the fever continued being high.  On Tuesday (09/26/17) we went back to the ER due to high fever. This time the dr said it looks more like coxsockie virus than strep and that we should just let it run it's course. On Thursday (09/28/17) we went back to his pediatrician's office and after examining pt she sent us back to the ER for some lab work because she suspected kawasaki disease. At the ER they did some blood work and urine tests and all results were within normal range so they ruled out Kawasaki disease and sent us back home. The added an additional antibiotic just in case and said if fever continues for 2 more days we should go back to ER for additional labs. Patient's last fever was on Friday (09/29/17) in the morning and the fever went down after he took motrin. The next day, Saturday 09/30/17 he developed a huge rash all over his body. We took him back to his pediatrician's office on Sunday 10/01/17 and she said it looks like fifth disease. He had the rash until Thursday 10/05/17 in addition to peeling skin on his hands and feet. It appears as if pt cough 4-5 contagious viruses although he hasn't been in daycare or any other place where he could have caught these viruses. Neither his 4 years old sister nor my husband and I caught any of these contagious viruses which just proves he didn't actually have them. What he had was a reaction to the MMR shot and his body was fighting the weakened live viruses that were injected in him.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Patient received the MMR shot (first dose) on Monday September 18th. 4 days later, on Friday September 22nd he developed a rash/hives all over his body. I initially thought it was a reaction to a food that contains eggs and gave him Benadryl; however, the rash wasn't getting any better. On Saturday (09/23/17) around 5 pm pt had high fever 103.7 and after a consultation with his pediatrician over the phone, we went to the closest emergency room. There, they did a swab test for strep and it was positive so they said he has strep and scarlet fever and prescribed amoxicillin for 10 days. By the next day the rash has gotten much better but the fever continued being high.  On Tuesday (09/26/17) we went back to the ER due to high fever. This time the dr said it looks more like coxsockie virus than strep and that we should just let it run it's course. On Thursday (09/28/17) we went back to his pediatrician's office and after examining pt she sent us back to the ER for some lab work because she suspected kawasaki disease. At the ER they did some blood work and urine tests and all results were within normal range so they ruled out Kawasaki disease and sent us back home. The added an additional antibiotic just in case and said if fever continues for 2 more days we should go back to ER for additional labs. Patient's last fever was on Friday (09/29/17) in the morning and the fever went down after he took motrin. The next day, Saturday 09/30/17 he developed a huge rash all over his body. We took him back to his pediatrician's office on Sunday 10/01/17 and she said it looks like fifth disease. He had the rash until Thursday 10/05/17 in addition to peeling skin on his hands and feet. It appears as if pt cough 4-5 contagious viruses although he hasn't been in daycare or any other place where he could have caught these viruses. Neither his 4 years old sister nor my husband and I caught any of these contagious viruses which just proves he didn't actually have them. What he had was a reaction to the MMR shot and his body was fighting the weakened live viruses that were injected in him.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Dystonia
Clinical narrative: RLE dystonia started the day following the vaccines given. Undergoing further evaluation at this time.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Feeling abnormal, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: During screening, pt did not mention any hx of passing out from shots.  I gave her the flu shot, approximately 5 minutes later, a coworker came running to tell me that she had passed out in the office lobby on the couch. A man was standing next to her, and I asked him to hold her head. Her eyes were rolling and she was pure white and sweating, and had a pulse. It seemed like she may have had a seizure as well. Receptionist called 911, and after about 4 minutes she came to and asked to sit up.  We put a cold paper towel on her forehead to help cool her down and she began to tell us this had been happening to her since she was a child. She said the flu shot really hurt her. The fire dept arrived first and spoke to her asking if she wanted to go to the hospital, etc, she said no, and they took her blood pressure. The paramedics arrived and took over, and when they went to prick her finger to do a blood sugar test, she said " I don't feel good" and passed out again, but this time had a more noticeable seizure. They took her by ambulance to hospital. Office staff reported that she had passed out at work about a month ago, however, they never saw it happen twice in a row. Her mom was called to meet her at the hospital.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: During screening, pt did not mention any hx of passing out from shots.  I gave her the flu shot, approximately 5 minutes later, a coworker came running to tell me that she had passed out in the office lobby on the couch. A man was standing next to her, and I asked him to hold her head. Her eyes were rolling and she was pure white and sweating, and had a pulse. It seemed like she may have had a seizure as well. Receptionist called 911, and after about 4 minutes she came to and asked to sit up.  We put a cold paper towel on her forehead to help cool her down and she began to tell us this had been happening to her since she was a child. She said the flu shot really hurt her. The fire dept arrived first and spoke to her asking if she wanted to go to the hospital, etc, she said no, and they took her blood pressure. The paramedics arrived and took over, and when they went to prick her finger to do a blood sugar test, she said " I don't feel good" and passed out again, but this time had a more noticeable seizure. They took her by ambulance to hospital. Office staff reported that she had passed out at work about a month ago, however, they never saw it happen twice in a row. Her mom was called to meet her at the hospital.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Pain in extremity, Personality change, Pyrexia
Clinical narrative: 48 hours - Fever. Sore leg - couple weeks. Inconsolable crying - 24 hours. Personality change - ongoing (never cried or fussed before, is unhappy a lot of the time now).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme shoulder and arm pain after vaccination with limited movement of L arm for 3-4 days and slow improvement thereafter.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Employee's arm has large, red, tender area around injection site.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: SEVERE BREAK OUT OF HIVES AND RASH FOR FOUR CONSECUTIVE DAYS. THEY COVERED 2/3 OF HIS BODY AT SOME TIMES. THE HIVES WOULD MOVE AROUND HIS BODY. THEY STARTED ON HIS TRUNK AND SPREAD OUT TO HIS FACE, HANDS, AND ANKLES BY THE THIRD DAY. VERY ITCHY.