chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included flu shot (Given in October). Concomitant products included cetirizine hydrochloride (Zyrtec), acetylsalicylic acid (Aspirin (Baby)) and fish oil. On 1st June 2018, the patient received SHINGRIX. On 1st June 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. In June 2018, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The nurse calling from physician office concerned that the vaccine they ordered which was administered by the pharmacy was administered at Inappropriate Site and possibly inappropriate route (subcutaneous vs intramuscular).  The nurse states that patient received SHINGRIX vaccine on Friday 1st June, 2018 and returned to office today 4th June 2018 presenting with a red (five inches in diameter), hot, painful spot on the back of the arm in the location where a subcutaneous administration would have occurred, not at deltoid.  These events have not resolved. The nurse did not know the lot number, name of pharmacist, etc.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 19th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site pain and local swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and local swelling were recovering/resolving. The reporter considered the injection site pain, injection site erythema and local swelling to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Approximately 16 days before the date of reporting, the patient received SHINGRIX in the left arm. Less than a month after vaccination, the patient experienced injection site soreness and raised bump. The patient also stated there was a small raised area towards the back area of the arm which was about less than the size of half inch by half inch. The redness was dominant for the first week after receiving the shot, and it had subsided a lot more than initially. The patient had denied permission to contact their physician. All questions were asked; no further details were provided.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Tuberculin test
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site induration in a 17-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included latex allergy (possible). On 24th May 2018, the patient received BEXSERO. On 29th May 2018, 5 days after receiving BEXSERO, the patient experienced injection site induration, injection site erythema and injection site muscle pain. On an unknown date, the outcome of the injection site induration and injection site muscle pain were unknown and the outcome of the injection site erythema was unchanged. The reporter considered the injection site induration, injection site erythema and injection site muscle pain to be possibly related to BEXSERO. Additional information reported as follows: The age at vaccination was not reported. The patient returned to the physician's office for a Purified protein derivative skin test (PPD test/ Tuberculin test), result not reported. The patient experienced local injection site reactions such as induration, tenderness, erythema and myalgia. After the PPD test, a bandage was applied and the patient developed a similar reaction. The physician believed that she might have an undiagnosed latex allergy. Lab Comments: On an unknown date, the patient underwent Tuberculin test (PPD test).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, 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 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm and difficulty sleeping. On an unknown date, the outcome of the pain in arm and difficulty sleeping were unknown. The reporter considered the pain in arm to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows; The pharmacist was the reporter told the Glaxosmithkline field representative that the patient was a 60 years old female. The patient told the pharmacist after receiving the 1st dose in the series on an unknown arm, her arm hurt so bad that she could barely sleep that night and that she could not believe how painful it was. By sometime the following day the symptom had resolved.  The reporter said the patient had since had the 2nd dose in the series and he had not heard from her since so he does not know if she had the same symptom after the second dose. No further details were provided by the reporter, so the vaccination dates are unknown and other dosing specifics are unknown. The reporter granted permission to be contacted. The Glaxosmithkline field representative assumed the vaccine was administered at the pharmacy but did not specifically asked for vaccine administration facility details.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 6th June 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In June 2018, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, the patient inadvertently received the SHINGRIX subcutaneously instead of intramuscular route, which led to inappropriate route of vaccination. The healthcare professional also mentioned that, the patient had severe localized reaction at the injection site. No other information was provided. The healthcare professional did not have lot number or expiry date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 64-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Concomitant products included fluoxetine hydrochloride (Prozac) and budesonide + formoterol fumarate (Symbicort). On 5th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 5th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching, injection site swelling, injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site itching, injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: During the assessment of the patient's arm, it was determined that, the SHINGRIX vaccine was given subcutaneously in the back of the patient's right arm, which led to Inappropriate route of vaccination. The patient experienced injection site reactions, described as, itching, swelling, redness and pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old male patient who received Shingrix (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 26th May 2018, the patient received the 1st dose of Shingrix (intramuscular) 1 dosage form(s). On 31st May 2018, 5 days after receiving Shingrix, the patient experienced rash (serious criteria other: as per reporter). The patient was treated with Antihistamines and Steroids. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be possibly related to Shingrix. Additional details were updated as follows: At 13:25, the patient received Shingrix. The patient had a rash all over his body except for his face. He visited the physician on 6th April 2018 and was prescribed an antihistamine and a steroid. Unrelated QA report was completed.
Age: 16.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Erythema, Nausea, Peripheral swelling, Skin warm, Somnolence
Clinical narrative: Patient became nauseous shortly after receiving the vaccines (approx. 5:30pm 6/12/18). Later in the evening her arm became red, swollen, and hot to the touch. She then vomited several times between 8pm and 11pm. Was able to keep down TYLENOL later in that time frame. She slept much of 6/13/18. Was feeling better when I called on 6/14/18 approx. 11am.
Age: 16.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient became nauseous shortly after receiving the vaccines (approx. 5:30pm 6/12/18). Later in the evening her arm became red, swollen, and hot to the touch. She then vomited several times between 8pm and 11pm. Was able to keep down TYLENOL later in that time frame. She slept much of 6/13/18. Was feeling better when I called on 6/14/18 approx. 11am.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported that on May 13 she had recieved the SHINGRIX and 2 days later the site of injection was red and sore. However, on 6/12 she experienced swollen and pain on the upper part of the left arm where the injection was given. This pain occurs primary after she wakes up in the morning.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe pain to shoulder joint - muscular pain as well, but joint pain severe.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: About 1 or 2 weeks later, started with fatigue/exhaustion and rash across chest. About 3 weeks after vaccination date went to pharmacist did not provide a treatment recommendation other than rest. Later called nurse. Today patient still has rash--it has not changed/improved--, but does not feel as tired as before. At the moment patient is dealing with others medical issues not related to this event. Patient reports that did not have problems after shingles vaccine years ago.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Rash, Rash macular, Rash vesicular
Clinical narrative: About 1 or 2 weeks later, started with fatigue/exhaustion and rash across chest. About 3 weeks after vaccination date went to pharmacist did not provide a treatment recommendation other than rest. Later called nurse. Today patient still has rash--it has not changed/improved--, but does not feel as tired as before. At the moment patient is dealing with others medical issues not related to this event. Patient reports that did not have problems after shingles vaccine years ago.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large warm red area at injection site left thigh.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient reported having fever, redness, soreness at and around the injection site. Recommend tylenol for the fever and ice pack to the site to help with the redness and swelling. 2 days later pt still had fever and also decided to take benadryl with Tylenol.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swollen from shoulder down to elbow, red hot to touch and painful started 6/13/2018 On 6/14/2018 was given KEFLEX 500mg TID x 10 days, elevation, ice and Ibuprofen.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site warmth, Lymphadenopathy, Nodule
Clinical narrative: Reports sore, enlarged nodule in right arm pit 3 days after receiving vaccine. Three days later, she reports that the nodule is smaller and not as sore, but now her deltoid feels firm and warm to touch but not red.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypersensitivity, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: Next morning (6-12-18)=numbness and tingling and pins and needles on left side of body and thighs. Predominant in arm and hand, radiating to left side of head and face. Feel ill. Sought medical attention at Emergency Room for Allergic reaction. 6-13-18=new areas of numbness and tingling and pins and needles began on left big toe. All other areas still numb/tingling from day of onset. 6-14-18=new areas of numbness and tingling and pins and needles began on ball of foot on left foot and shin area of left leg. Also on face by nose, predominantly left side. All other areas still numb/tingling from day of onset. Advised to watch and wait to report if difficulty breathing or muscle weakness or fatigue occur.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Balance disorder, C-reactive protein normal, Electromyogram abnormal, Eyelid ptosis, Head discomfort
Clinical narrative: Next morning (6-12-18)=numbness and tingling and pins and needles on left side of body and thighs. Predominant in arm and hand, radiating to left side of head and face. Feel ill. Sought medical attention at Emergency Room for Allergic reaction. 6-13-18=new areas of numbness and tingling and pins and needles began on left big toe. All other areas still numb/tingling from day of onset. 6-14-18=new areas of numbness and tingling and pins and needles began on ball of foot on left foot and shin area of left leg. Also on face by nose, predominantly left side. All other areas still numb/tingling from day of onset. Advised to watch and wait to report if difficulty breathing or muscle weakness or fatigue occur.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Muscle twitching, Muscular weakness, Neuralgia
Clinical narrative: Next morning (6-12-18)=numbness and tingling and pins and needles on left side of body and thighs. Predominant in arm and hand, radiating to left side of head and face. Feel ill. Sought medical attention at Emergency Room for Allergic reaction. 6-13-18=new areas of numbness and tingling and pins and needles began on left big toe. All other areas still numb/tingling from day of onset. 6-14-18=new areas of numbness and tingling and pins and needles began on ball of foot on left foot and shin area of left leg. Also on face by nose, predominantly left side. All other areas still numb/tingling from day of onset. Advised to watch and wait to report if difficulty breathing or muscle weakness or fatigue occur.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Ocular discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Next morning (6-12-18)=numbness and tingling and pins and needles on left side of body and thighs. Predominant in arm and hand, radiating to left side of head and face. Feel ill. Sought medical attention at Emergency Room for Allergic reaction. 6-13-18=new areas of numbness and tingling and pins and needles began on left big toe. All other areas still numb/tingling from day of onset. 6-14-18=new areas of numbness and tingling and pins and needles began on ball of foot on left foot and shin area of left leg. Also on face by nose, predominantly left side. All other areas still numb/tingling from day of onset. Advised to watch and wait to report if difficulty breathing or muscle weakness or fatigue occur.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Red blood cell sedimentation rate normal, X-ray limb
Clinical narrative: Next morning (6-12-18)=numbness and tingling and pins and needles on left side of body and thighs. Predominant in arm and hand, radiating to left side of head and face. Feel ill. Sought medical attention at Emergency Room for Allergic reaction. 6-13-18=new areas of numbness and tingling and pins and needles began on left big toe. All other areas still numb/tingling from day of onset. 6-14-18=new areas of numbness and tingling and pins and needles began on ball of foot on left foot and shin area of left leg. Also on face by nose, predominantly left side. All other areas still numb/tingling from day of onset. Advised to watch and wait to report if difficulty breathing or muscle weakness or fatigue occur.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 12x15cm of warmth, redness surrounding injection site (Left quad).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, headache, nausea.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Nausea, vomiting, HA, muscle aching, sore throat, (Lt) arm hurting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, HA, muscle aching, sore throat, (Lt) arm hurting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Toothache
Clinical narrative: Radiating tooth pain.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient called clinic with concern of 1.5 in dia. redness around injection site and some soreness.  Will monitor site, apply ice and OTC ibuprofen. Will contact clinic for appointment if not improving.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash, Rash vesicular, Swelling
Clinical narrative: Day 1 post-immunization: localized erythema; Day 3 post-immunization: localized vesicular rash & surrounding tissue erythematous and swollen; Treatment: patient prescribed acyclovir & gabapentin on Day 3 post-immunization.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever 105 degrees orally, vomiting and severe body aches lasting for 48 hours.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, chills.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: By evening on 1st day swollen and sore at shot site. Headache. By next morning rash along both inside arms, across chest and all around torso. Lasted 3 days, then acute itching for 3 days. Unable to lift left arm higher than shoulder for over one week without aching muscles round site of shot. Ok now but still a blue/black bruise where shot given.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: By evening on 1st day swollen and sore at shot site. Headache. By next morning rash along both inside arms, across chest and all around torso. Lasted 3 days, then acute itching for 3 days. Unable to lift left arm higher than shoulder for over one week without aching muscles round site of shot. Ok now but still a blue/black bruise where shot given.
Age: 74.0
Sex: U
Vaccine: FLUA3
Symptoms: Hypoaesthesia
Clinical narrative: Patient received flu shot on 9/16/17. Came in 6/3/18 claiming that since she got the shot, her elbow has been numb.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: I gave the patient the correct vaccine, but it had expired on 5-28-18 and I gave the vaccine on 6-12-18. The expired vaccine was Tdap BOOSTRIX.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Borrelia test negative, Fatigue, Headache, Malaise, Pain
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an approximately 11 year old male patient (according to the reporter, the patient is currently "20 or 21 years old"). Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date approximately in 2008 (also reported "when he was 11 years old"), the patient was vaccinated with the first dose of GARDASIL Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). Subsequently, he was vaccinated with the second dose of GARDASIL Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported) also approximately in 2008. The reporter stated that approximately in 2008 (also reported as "sometime after the patient received a second dose of GARDASIL, the patient began experiencing body aches, fatigue and headache which had persisted for 10 years. The nurse informed that the patient was initially tested for Lyme disease on an unknown date, but tests were negative. It was also reported that the patient was currently functional but not feeling well (the onset date of this event was not reported). He sought medical attention, but it was not known if any treatment was given for the events. The outcome of the events of body aches, fatigue, headache and malaise were reported as not recovered. The causal relationship between the events and vaccination with GARDASIL was reported as unknown (also reported as "they weren't sure if his symptoms were associated with GARDASIL; however, the patient's grandmother stated the symptoms began after the patient received the second dose of GARDASIL.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-JUL-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 of herpes zoster. On or about 29-JAN-2016, the patient was treated at a family medicine office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster with complications. As a direct and proximate result of the ZOSTAVAX 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 on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician 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 of herpes zoster. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX 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
Clinical narrative: This spontaneous report was received from a consumer via company representative. The consumer was reporting about her mother, a female patient on an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (also reported as (unspecified) shingles vaccine) for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient experienced shingles (also reported as lack of therapeutic efficacy). At the reporting time, the patient was going to receive another shingles vaccine: SHINGRIX, due to the event. The outcome of the vent was not reported. The relatedness between the event and zoster vaccine live (manufacturer unknown) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician at a healthcare facility/office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 21-SEP-2014, the patient was treated by the physician at the healthcare facility/office, for a blistering vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation. A male patient, age and history not provided, was inoculated at a physician's office with ZOSTAVAX in 2012 for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX was supposed to prevent. In 2015 the patient was treated at a physician's office and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the 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. Outcome of shingles was not provided. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Product quality issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included TWINRIX. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the 1st dose was an unknown dose. On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fever and pharmaceutical product complaint were unknown. The reporter considered the fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The lot number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. On the same day, the patient received the 1st dose of TWINRIX on an unknown arm. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Shingrix (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Concomitant products included ADACEL. On 26th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 26th May 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain and pharmaceutical product complaint were unknown. The reporter considered the injection site pain to be almost certainly related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the right arm. On the same day, the patient received the 1st dose of Adacel concomitantly. The batch number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving Shingrix injections since January 2018 and said that this last batch of Shingrix might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) and (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose on an unknown date). Concomitant products included ADACEL. On 4th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site warmth. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site swelling, injection site warmth and pharmaceutical product complaint were unknown. The reporter considered the injection site swelling and injection site warmth to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 26th May 2018, the patient received 1st dose of ADACEL on the left arm. The patient received 2nd dose of SHINGRIX on the left arm. The lot number of the adjuvant/liquid was D3L5G with an expiry of 11/29/2020. The pharmacist reported that he had been giving SHINGRIX injections since January 2018 and said that this last batch of SHINGRIX might be suspect. He reported that the patient experienced Adverse drug reactions (ADE's) unlike previous injections. The reporter did not have any product to return and was not seeking reimbursement. When asked, the pharmacist reported there was nothing unusual about the vials or the box. The side effect profile and percentages of ADEs experienced were reviewed. The pharmacist also reported via VAERS. This case is 1 of the 7 linked cases reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Fibromyalgia, Narcolepsy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of narcolepsy in a 60-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis.  Concomitant products included Tetanus NVS (Tetanus vaccine). In June 2013, the patient received Rabies Vaccine. In June 2013, less than a month after receiving Rabies Vaccine, the patient experienced narcolepsy (serious criteria GSK medically significant) and fibromyalgia. On an unknown date, the outcome of the narcolepsy and fibromyalgia were not recovered/not resolved. It was unknown if the reporter considered the narcolepsy and fibromyalgia to be related to Rabies Vaccine. Additional details were provided as follows: Concomitant products included as immunoglobulin. The Rabies Vaccine (unknown manufacturer) was used for post-exposure prophylaxis. The patient planned to continue follow-up with her physician on an unknown date.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal pain, Neck pain, Paraesthesia, Pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of pruritus in a 65-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza Vaccine (gets flu shots but had never experienced an effect like this before) and Niacin (experienced similar symptoms but this was not as extreme). Concomitant products included CRESTOR. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th June 2018, 1 hr after receiving SHINGRIX, the patient experienced pruritus, tingling sensation, shoulder pain and neck pain. On 5th June 2018, the patient experienced tiredness. On an unknown date, the outcome of the pruritus, tingling sensation, shoulder pain, neck pain and tiredness were recovering/resolving. The reporter considered the pruritus, tingling sensation, shoulder pain and neck pain to be probably related to SHINGRIX. The reporter considered the tiredness to be possibly related to SHINGRIX. Additional details were provided as follows: At 09:20 hours, the patient received SHINGRIX in the left arm. Shortly after vaccination (1 hour), the patient experienced tingly or itchy feeling in both arms, more noticeable in left arm which was arm of injection. Less than a day after vaccination, the patient experienced soreness in his shoulder and on the left side of his neck. The condition was improving on 5th June 2018. One day after vaccination, the patient experienced tiredness. The patient was asking if this was a possible side effect from SHINGRIX. The patient also asked to the pharmacist who gave injection and she did not know. The patient had placed her call to her physician and was still awaiting call back. The patient was not experiencing other symptoms. The patient stated the response was appreciated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The nurse practitioner and office manager reported this case. The patient experienced significant swelling and redness. The reporter agreed for follow up contact.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via other and described the occurrence of influenza-like symptoms in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like for a week. The health care professional was concerned about 2nd dose compliance, as patient was worried about the symptoms reoccurring.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, she got a mild case of shingles, diagnosed via her physician, two weeks after receiving the 1st dose of Shingrix. Shingles started on her left side of arm, and across her back to the right side of her breast. The patient thought that, the event was related to the Shingrix. The nurse did not think the event was related to the Shingrix. The nurse agreed to be followed up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Influenza like illness, Pain
Clinical narrative: Patient stated that she woke up the next morning following her vaccine administration feeling flu-like symptoms. She was achy/sore over her entire body and felt cold. The symptoms lasted for a day or two. She received the second dose in the series on 6/14/18, which was when she reported the side effects she experienced from the initial dose in the series.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Fatigue, Hyperhidrosis, Lethargy
Clinical narrative: This is the second of the 2 vaccines. Both times, the next day, I felt fatigued, sweaty, blood pressure drop to the point of lying down with feet up for about 30 min. Today, I'm still feeling very tired and lethargic.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, CSF glucose increased, CSF lymphocyte count increased, CSF protein increased, CSF test abnormal
Clinical narrative: Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: CSF virus identified, Electrophoresis protein, HIV test negative, Herpes zoster disseminated, Herpes zoster meningoencephalitis
Clinical narrative: Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyporeflexia, Immunoglobulins normal, Mental status changes, Muscular weakness, Neck pain
Clinical narrative: Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral motor neuropathy, Rash vesicular, Varicella virus test positive
Clinical narrative: Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Erythema, Lumbar puncture abnormal, Polymerase chain reaction positive, Rash
Clinical narrative: Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin exfoliation, Skin lesion, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient's arm is hot, red and painful. Patient realized of symptoms when she woke up the morning after the immunization was given. Patient will take BENADRYL tablets, use Hydrocortisone cream and ice packs for now. Advised to seek medical attention if reaction gets worse.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: Acute onset headache, significant fatigue, "felt terrible" for 5 days. There was no rash, no injection site pain.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram normal, Eye movement disorder, Head injury, Musculoskeletal stiffness, Syncope
Clinical narrative: As pt was checking out, after she received vaccinations, she fainted and hit her head on the wall, leaving a small punched out area on the sheet rock. She responded to stimulation and awoke after 15 s. Her pulse was steady in the 70s and pulse ox 99%. During that time, there was questionable stiffening and tremor of arms, and eyes seemed to be rolling. Then she awoke. She recognized her grandmother, responded to questions, and then sat up. EMS was called and she was transported to the ER for further evaluation.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: As pt was checking out, after she received vaccinations, she fainted and hit her head on the wall, leaving a small punched out area on the sheet rock. She responded to stimulation and awoke after 15 s. Her pulse was steady in the 70s and pulse ox 99%. During that time, there was questionable stiffening and tremor of arms, and eyes seemed to be rolling. Then she awoke. She recognized her grandmother, responded to questions, and then sat up. EMS was called and she was transported to the ER for further evaluation.