chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Death, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 15 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in 2011 (at her age of 11), the patient was vaccinated with first dose of GARDASIL 9 (anatomical location, dose, route, frequency, expiration date and lot number were not specified) as prophylaxis. Thereafter, the patient received her second and third dose on an unknown date in 2015 (reported as 4 years later) and in November 2015 respectively (inappropriate schedule of drug administration). In January 2016, the patient died (death) when she was 15 years old. It was unknown, if any lab diagnostics/studies were performed. The cause of death was unknown. It was unknown, if an autopsy was performed. The reporter did not assess the causality of the event death with GARDASIL 9. Product quality complaint was not involved.; Reported Cause(s) of Death: Unknown.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse refers to a 8 week 5 days old male patient. The patient's concurrent conditions were not reported. The patient's historical condition included breech in third trimester. The patient's drug reactions and allergies were not reported. The patient's concomitant medications included hepatitis b virus vaccine, pneumococcal conj vaccine and PENTACEL. On 03-APR-2018, the patient was vaccinated with ROTATEQ (dose, units and frequency not reported) (lot # N032566 and expiration date: 01-MAY-2019) orally. It was reported that, on 03-APR-2018 (also reported as 04-JUL-2018) ROTATEQ was stored at a temperature that was greater than 8 degree Celsius (C) (product storage error). The administered vaccine with the lot# N032566 was stored outside of required temperature range on 26-MAR-2018, and kept in required temperatures until 27-MAR-2018. It was mentioned that the physician and manufacturer notified based on the data received from the global medical, it was determined that the stability and potency of the ROTATEQ could not be supported. A letter was sent to patient's parents to let them know about the situation and appointment has been made to revaccinate the patient at free of charge. This is one of the reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse refers to a 1 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medications included VAQTA. On 21-MAR-2018, the patient was vaccinated with M-M-R II (dose, units and frequency not reported) (lot # N020922 and expiration date: 01-AUG-2019) subcutaneously. On 18-JAN-2018, manufacturer received vaccine with Lot # N020922, from the time it was received it was stored properly in the refrigerator in temperatures between 2 to 8 C. On further review, on 03-APR-2018, it was determined that, the temperatures had been out of range that is greater than 8 C (product storage error). This issue has been notified to manufacturer and received information from global information medical scientist, dose would need to be repeated. A letter was sent to patient's parents to let them know about the situation and appointment has been made to revaccinate the patient.
Sex: F
Vaccine: HPVX
Symptoms: Abdominal discomfort, Lymphadenopathy, Syncope
Clinical narrative: This spontaneous report as received from a consumer via Pfizer refers to a 17 year old female patient. The patient's medical history, concurrent conditions, concomitant medication were not reported. On an unknown date (also reported one or two years ago) when the patient was 15-16 year old, she was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (lot, expiry date, dose, route of administration were not reported) (or) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) (lot, expiry date, dose, route of administration were not reported) for prophylaxis. When she had the initial HPV vaccine, she had a really bad reaction that included tennis ball size lymph nodes under her arms (lymphadenopathy). On an unknown date of June 2018, the patient experienced upset stomach, which was worst on 10-JUN-2018, syncope and swollen lymph nodes (lymphadenopathy). The patient stated that as long as she is not super active, she seems to be feeling better. The reporter stated that the patient's lymph node under her left arm is worse than the right. The outcome of abdominal discomfort was reported as recovered. The outcome of all other adverse events were reported as unknown. The causality assessment was not provided by the reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Achy joints (all joints).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about, 01-MAR-2013, the patient was inoculated 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 to contract a persistent strain of herpes zoster. On or about 19-OCT-2015, the patient was treated by a physician for a vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-DEC-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 20-OCT-2011, the patient was treated by a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to clinic c/o possible vaccine reaction. Received RZV immunization, series #2, on 7/3/18 R deltoid. States later the same evening he noted a red, burning, itchy area over R deltoid and mid upper arm which has gotten larger. Area is hot to touch, sl swollen, approx 4x3 inch. Denies rxn to series #1. Denies any insect bites, injury to area, or any exposure to new detergents, soaps. Denies breathing difficulty, throat swelling, facial swelling. Full AROM to arm and shoulder. VSS, afebrile. Advised to take TYL or MOTRIN and BENADRYL per OTC instructions, to apply cold packs x20 intervals, to report to ER if any difficulty breathing, throat or facial swelling, and to call the clinic on Monday if no improvement. Patient verbalizes understanding and agrees to plan.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Mobility decreased
Clinical narrative: Had full body joint aches, could not lie down to sleep due to the aches - took 600mg ibuprofen and that seemed to help. Felt better starting 7/6/18 and is able to move around better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pruritus, Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph nodes under arm swollen over 6" to convex, itchy at injection site, upper arm pain, chills.  This second shot was a walk in the park to the reaction of the first shot. Itchy went away for 24 hours after a workout. All of the reactions were gone in just a few days this time.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Blood creatine phosphokinase increased, Chills, Fatigue, Myalgia
Clinical narrative: Chills, fatigue, muscle aches, weakness, arms tingling elevated. During pts stay in the clinic, sx became worse and was referred to another clinic.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Chills, fatigue, muscle aches, weakness, arms tingling elevated. During pts stay in the clinic, sx became worse and was referred to another clinic.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: Chills, fatigue, muscle aches, weakness, arms tingling elevated. During pts stay in the clinic, sx became worse and was referred to another clinic.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Fatigue, Hypersomnia
Clinical narrative: Severe stomach cramping and pain, dizzy, light headed, diarrhea, extreme fatigue (sleeping almost 20 hours a day).
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Pharyngeal oedema, Rash
Clinical narrative: 15 MINUTES AFTER RECEIVING ADACEL, PATIENT EXPERIENCED MINOR RASH AROUND THE NECK LINE AND BOTH ARMS. SHE ALSO FELT SOME SWELLING ON THE THROAT, BUT NO DIFFICULTY OF BREATHING. 25MG DIPHENHYDRAMINE WAS ADMINISTER BY MOUTH IMMEDIATELY WHEN THE PATIENT REPORTED THE ALLERGY SYMPTOMS. 5 MINUTES AFTER DIPHENHYDRAMINE DOSE, THE PATIENT FELT BETTER, THE RASH SUBSIDED, NO THROAT SWELLING WAS FELT.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: Acute gout attack.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Diarrhoea, Malaise, Nausea, Urticaria
Clinical narrative: Experienced nausea 4 hours after vaccine. The next day experienced nausea, diarrhea, temp of 101.5. "Couch bound" sick x 1 day. 2 days after vaccination noted hives on trunk, back and neck. No shortness of breath nor reaction to previous vaccines. She called her primary care provider and was advised to take ZYRTEC 2 tabs/twice a day. Did not have physical exam after reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pain, Pain in extremity, Tremor
Clinical narrative: Right arm became very sore by 8 hrs post injection. Then had whole body shakes and chills and severe body aches for the next 4-5 hrs and was unable to sleep. I used TYLENOL and KLONOPIN to address the response, which seemed to help after a few hours.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient had pain, redness and swelling for 2 weeks after the first shot.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Computerised tomogram head, Febrile convulsion, Full blood count, Metabolic function test normal
Clinical narrative: Complex Febrile Seizure. 102 sudden onset. No illness. CT scan. All labs neg. 24 hour hosp obs. Infant fine since with no other fever. No sick contacts.
Age: 55.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Erythema, Oropharyngeal pain, Peripheral swelling, Pruritus, Sensory disturbance
Clinical narrative: Patient's left shoulder became a little swollen and red. Patients stated she could feel the vaccine in the left side of her neck and left side of head. Applied ice to left shoulder and after 30 minutes, Patient stated she felt better. Swelling and erythema had subsided. The next day contacted patient and she reported itching to her ear and a little sore throat. Advised to go to urgent care clinic or PCP. Went to Clinic and was prescribed prednisone. Patient also took BENADRYL.
Age: 55.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Ear pruritus, Erythema, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Patient's left shoulder became a little swollen and red. Patients stated she could feel the vaccine in the left side of her neck and left side of head. Applied ice to left shoulder and after 30 minutes, Patient stated she felt better. Swelling and erythema had subsided. The next day contacted patient and she reported itching to her ear and a little sore throat. Advised to go to urgent care clinic or PCP. Went to Clinic and was prescribed prednisone. Patient also took BENADRYL.
Age: 55.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Oral disorder, Oropharyngeal pain, Pharyngeal lesion
Clinical narrative: Patient's left shoulder became a little swollen and red. Patients stated she could feel the vaccine in the left side of her neck and left side of head. Applied ice to left shoulder and after 30 minutes, Patient stated she felt better. Swelling and erythema had subsided. The next day contacted patient and she reported itching to her ear and a little sore throat. Advised to go to urgent care clinic or PCP. Went to Clinic and was prescribed prednisone. Patient also took BENADRYL.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Fever, headache and dizziness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Middle insomnia, Pruritus, Rash macular, Skin warm
Clinical narrative: Skin felt hot and itchy and turned red and blotchy on neck, face, torso, arms and upper legs. Took BENADRYL and it went away. Symptoms reappeared at 3:00 am July 4 waking me up. Took BENADRYL and symptoms went away.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 08-JUN-2018, the patient was vaccinated with improperly stored dose of PROQUAD, first dose, subcutaneously in left arm for prophylaxis, lot# N002916, expiration date 24-JUL-2018. The vaccine was reconstituted with properly stored sterile diluent (lot# reported as M041813, expiration date 27-MAY-2019). The vaccine underwent a temperature from 6°F to 14°F (14.3 °F) for 5 minutes, and from 15 °F to 46°F (20.7 °F) for 15 minutes. The patient had no illness at the time of the vaccination. There was no adverse event reported. The call was because of digital data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-JUN-2018, the patient was vaccinated with properly stored but expired PROQUAD, lot # M049122 and expiration date on 13-JUN-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported and no product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated at an emergency care center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. Also, on an unknown date in 2015, the patient sought subsequent treatment for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the 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 did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-MAR-2016, the patient was treated by a nurse practitioner for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JAN-2016, the patient was treated by a physician at a medical center for a vesicular outbreak, which was then diagnosed as herpes zoster conjunctivitis. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Upon internal review, herpes zoster conjunctivitis was considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager refers to 12 week old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 17-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ orally, lot# M038209 with an expiration date 23-APR-2018 and lot# M041768 with an expiration date 25-JUN-2018. (dose was not reported). Reporter stated that the vaccine was deemed stable. There was no adverse effect reported. No product quality complaint was involved. Administered doses of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 27 hours. Data logger was involved. There were previous excursions reported (from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 27 hours and form 47 degrees Fahrenheit to 77 degrees Fahrenheit for 27 hours). This is one of the report received from the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 74-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 61 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed herpes zoster approximately 2 months after receiving SHINGRIX. The health care professional had reached out to the patient for schedule dose 2 of SHINGRIX and when he got know that the patient had an active case of herpes zoster. The health care professional did not speak to the patient directly at that time. The health care professional would soon reach out to determine if there was treatment or symptoms resolved. The batch number updated from 324KL to 3Z4KL as per sales data sheet.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 10th April 2018 10:45, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. In 2018, the patient experienced soreness in her arm for 3 weeks and it had not completely resolved. On 25th June 2016, the patient went to the pharmacy to get her 2nd dose of SHINGRIX. The 2nd dose was not administered as the pharmacist was looking for more information about this situation before giving it. The patient did want to get the 2nd dose.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 82-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension and hyperlipidemia. Concomitant products included LIPITOR, Losartan and metoprolol. On 22nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site tenderness. On 23rd June 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the injection site tenderness was recovering/resolving. The reporter considered the injection site erythema, injection site tenderness and injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: One day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In June 2018, the injection site erythema and injection site swelling were resolved. The patient had denied permission to contact their physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema. Concurrent medical conditions included blood pressure and hypothyroidism. Concomitant products included Aspirin, Calcium, LIPITOR, PROLIA, Ranitidine, valsartan, Vitamin D3 and ZYRTEC. On 29th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness. On an unknown date, the outcome of the injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness were recovered/resolved. The reporter considered the injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the left arm. The patient experienced raised, hot, red area at the injection site which was about the size of her hand. The hot and raised area lasted for total of one week. The patient also felt sore muscle, trouble sleeping, tired, and pain which lasted for total of 1 week. The redness at the injection site lasted for total 2 weeks. One and half week after receiving the SHINGRIX vaccine, the patient had itching at the injection site, which lasted for 4 days. The patient gave permission to contact their healthcare provider. No further details were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema. Concurrent medical conditions included blood pressure and hypothyroidism. Concomitant products included Aspirin, Calcium, LIPITOR, PROLIA, Ranitidine, valsartan, Vitamin D3 and ZYRTEC. On 29th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness. On an unknown date, the outcome of the injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness were recovered/resolved. The reporter considered the injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the left arm. The patient experienced raised, hot, red area at the injection site which was about the size of her hand. The hot and raised area lasted for total of one week. The patient also felt sore muscle, trouble sleeping, tired, and pain which lasted for total of 1 week. The redness at the injection site lasted for total 2 weeks. One and half week after receiving the SHINGRIX vaccine, the patient had itching at the injection site, which lasted for 4 days. The patient gave permission to contact their healthcare provider. No further details were provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown. The reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The reporter stated that the patient reported to him that at some point after receiving the SHINGRIX vaccine, he experienced an itchy rash on his chest. The reporter did not have any additional details regarding the rash.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site infection and inappropriate route of vaccination. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site infection were not recovered/not resolved and the outcome of the inappropriate route of vaccination was unknown. The reporter considered the injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and injection site infection to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX subcutaneously which led to inappropriate route of vaccination and had reported redness, swelling and infection at injection site. The healthcare professional (HCP) did not provide patient's date of birth and lot number or expiry date of SHINGRIX. The HCP was driving at the time of reporting and had limited information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 19th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient experienced redness and swelling of 3 mm at the injection site. In 2018, injection site erythema and injection site swelling lasted for 3 days and resolved. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a adult female patient who received SHINGRIX (batch number 27K24, expiry date unknown) for prophylaxis. On 21st June 2018, the patient received SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced chills, fever, myalgia and fatigue. In June 2018, the outcome of the chills, fever, myalgia and fatigue were recovered/resolved. The reporter considered the chills, fever, myalgia and fatigue to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient reported adverse event to the office on 23rd June 2018 and on 25th June 2018, the patient was checked. The adverse events were lasted for 48 hours and subsided. The reporter did not agree for follow up from GlaxoSmithKline. This case has been linked to the case US2018GSK115511, reported by the same reporter.
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Injection site pain, Lacrimation increased
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received TRUMENBA, (Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 27Jun2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient had pain at the injection site for 3 days. She had a headache behind her eyes and her eyes are watering. The outcome of the event pain at the injection site was recovered on unspecified date. The outcome of other reported events was unknown. Information on the batch/lot number has been requested.
Sex: F
Vaccine: MENB, MENB
Symptoms: Eye pain, Headache, Lacrimation increased
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received TRUMENBA, (Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 27Jun2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient had pain at the injection site for 3 days. She had a headache behind her eyes and her eyes are watering. The outcome of the event pain at the injection site was recovered on unspecified date. The outcome of other reported events was unknown. Information on the batch/lot number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site reaction, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at a single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, vomiting, headache, and injection site reaction on an unspecified date and inquired if she will have a severe reaction if she gets another dose. The outcome of the events was unknown.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Parents noticed warm, red area at injection site around 8:00 pm 7/5/2018. Parent called office today because area had increased to half dollar size and seemed tender. No fever or streaking. Will monitor and follow-up as needed.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Fatigue, Irritability, Pyrexia
Clinical narrative: Fussiness, fatigue, fever (maxed temp recorded 102.2).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Pain in extremity, Tremor
Clinical narrative: After administration of vaccine, client stated his arm hurt. Advised client to move arm around and client stated "I feel like I'm going to faint." Client assisted with transfer to cot and placed in lying position with knees bent. Client given juice to drink. Client's legs began shaking as if he was shivering. Client had color in cheeks and was not diaphoretic. Arms and body began shivering. Client stated "when I try to move I shake more. Client advised to relax on cot and take slow deep breathes. Pulse 84 beats per minute. Client understood. Client alert and oriented to person, place, and time. After ten minutes, client sat up on cot. Stated he was feeling better. Client was a stand-by assist to sit in chair, no longer shaking. After 5 more minutes of observation, client able to walk to car.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Throat tightness, Tinnitus
Clinical narrative: Patient returned to ED later that day with dizziness, ringing in ears, and tight feeling in throat. Denied SOB, fever, chills, rash.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature decreased, Chills, Heart rate increased, Hyperhidrosis
Clinical narrative: Initially I only had pain at injection site. Several days later I broke out in rashes that at the time I thought was poison ivy. I went to a clinic where the nurse practitioner informed me of a temperature of 100.7. Since I never had poison ivy before and she was unsure how allergic I was, she decided to prescribe prednisone but told me also that fever is rare with poison ivy. At the time I didn't even think it was possible since I had several days where I felt fine. It wasn't until late last night when my temperature on two separate thermometers was 95.9 where I became concerned and started doing my own research. Today the rashes are almost gone and we're never as itchy as poison ivy is described. I will be going to the hospital today for bloodwork to determine whether it's a reaction or a form of pneumonia. Other symptoms include rash on left side of neck and arm as well as my back. Chills, sweating, fever, low temp 2 degrees below normal, elevated heart rate and joint pain. Also temporary numbness in left leg.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: Initially I only had pain at injection site. Several days later I broke out in rashes that at the time I thought was poison ivy. I went to a clinic where the nurse practitioner informed me of a temperature of 100.7. Since I never had poison ivy before and she was unsure how allergic I was, she decided to prescribe prednisone but told me also that fever is rare with poison ivy. At the time I didn't even think it was possible since I had several days where I felt fine. It wasn't until late last night when my temperature on two separate thermometers was 95.9 where I became concerned and started doing my own research. Today the rashes are almost gone and we're never as itchy as poison ivy is described. I will be going to the hospital today for bloodwork to determine whether it's a reaction or a form of pneumonia. Other symptoms include rash on left side of neck and arm as well as my back. Chills, sweating, fever, low temp 2 degrees below normal, elevated heart rate and joint pain. Also temporary numbness in left leg.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Fever 100.5 F ........ chills ....... dry cough ...... headache ...... body ache ....... all lasted 6+ hours.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In 2014, the patient was inoculated 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 to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center for a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic pain. On 27th June 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 12 hrs after receiving SHINGRIX, the patient experienced general body pain and unable to walk. On an unknown date, the outcome of the general body pain and unable to walk were recovering/resolving. It was unknown if the reporter considered the general body pain and unable to walk to be related to SHINGRIX. Additional details were provided as follows: On the day before reporting, around 5:00pm, the patient received SHINGRIX in the right arm. The patient went to bed around 11:00pm and then experienced pain that woke her up around 5 to 6 am. The patient's entire body was in pain and she was not able to move or walk. The patient managed to go back to sleep then woke up again around 7:00 or 8:00am and still had pain. The patient went back to sleep until 10:00am and the pain had lessened and she could function. The patient did not know the lot number and expiration date of the vaccine. The patient has denied permission to contact their physician. The patient did not have a primary care doctor.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. In June 2018, several weeks after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: In first week of June 2018, the health care professional reported that the patient experienced shingles a few weeks after receiving the dose of the SHINGRIX series. The health care professional was not sure of lot number either it was C523T or Cs23T.  The health care professional could not read the writing.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 55-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date July 2020) for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site muscle pain and injection site swelling. The patient was treated with MOTRIN, TYLENOL and Lidocaine Cream. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site muscle pain and injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The swelling resolved but the pain was continued as of the date of reporting. The patient went to the doctor. The doctor suggested taking MOTRIN, TYLENOL and lidocaine cream. No further information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Developed fever and chills 8-12 hrs post injection associated with arthralgia myalgias, redness inferior to injection site. Temp greater than or equal to 102, with persistant fever 5 days post injection.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site reaction, Macule
Clinical narrative: Erythematous macule with few fine papular lesions left deltoid region onset same day as Tetanus vaccine given in that location.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Rash papular
Clinical narrative: Erythematous macule with few fine papular lesions left deltoid region onset same day as Tetanus vaccine given in that location.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis surrounding injection site on left thigh, prescribed cephaliexin
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Fatigue, Headache, Herpes zoster
Clinical narrative: 5-13-18 - shingles Famciclovir - headache. 6-4-18 - shingles - Famciclovir - tired. 6-6-18 - gave info on shingles - chills. 6-13-18 - shingles - Famciclovir - blisters. 6-20-18 - Blisters on stomach - itchy and mild pain. 6-21-18 - under breast chicken pox? -Acyclovir. cream
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: 5-13-18 - shingles Famciclovir - headache. 6-4-18 - shingles - Famciclovir - tired. 6-6-18 - gave info on shingles - chills. 6-13-18 - shingles - Famciclovir - blisters. 6-20-18 - Blisters on stomach - itchy and mild pain. 6-21-18 - under breast chicken pox? -Acyclovir. cream
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Infection, Neuropathy peripheral, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-DEC-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-DEC-2015, the patient was treated for an infection caused by the blistering vesicular outbreak of herpes zoster or shingles, which was diagnosed as peripheral neuropathy. On or about 22-JAN-2016, the patient sought subsequent treatment for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR and acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Upon internal review, peripheral neuropathy was determined to be medically significant. Additional information has been requested.