chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA303390. This case involves a 24 months old male patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (lot UT6259LA and Exp. Date 30 Jun 2019) via intramuscular route in the left thigh on 29-Oct-2018, which was stored at negative 8 Cel. hence had temp excursion. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. There was no reported reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 67 years old female patient who experienced swelling at injection site, red swatches and they were hot to the touch and bruising at the injection site about 1.5 inches in diameter, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. On 19-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ004AB, expiration date 30-Mar-2019) via intramuscular route in the left deltoid. The patient developed a non-serious swelling at injection site, red swatches and they were hot to the touch that lasted for several days, and bruising at the injection site about 1.5 inches in diameter following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was bruising at the injection site about 1.5 inches in diameter, red swatches and they were hot to the touch and swelling at injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling at injection site and bruising at the injection site about 1.5 inches in diameter, and as Recovered / Resolved on an unknown date for red swatches and they were hot to the touch.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves adult patient who was vaccinated with PENTACEL (batch number: C5439AA, expiration date: 29-Jun-2019, route was not reported, in left side) instead of a FLUZONE HD, on 30-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: My heart was in A-Fib the following day.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Pt presented next day with drooping of left side of face--Bell's palsy.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Peripheral swelling, Vaccination site swelling
Clinical narrative: Patient reported redness and swelling over whole arm where vaccine was given. Patient was prescribed doxycycline 100 mg and methylprednisolone 4 mg dose pack on the day after vaccination. Patient was being treated for cellulitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pain in extremity, Somnolence
Clinical narrative: 1st  day sore arm & tired. Then, folowing morning. sever pain around injection site & sore arm from shoulder to elbow. At 9:00 am, sever body pain & aches, sever tired feeling. I had to stay in bed & took 2 Alieve caplets, slept all day long with periods of waking with body aches. NOTE: I had the flu shot 1 week prior at my doctor's office.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Immunisation, Occupational exposure to product, Syringe issue
Clinical narrative: SYRINGE WAS CRACKED AND AS I GAVE SHOT FLUID CAME OUT THROUGH THE BOTTOM OF SYRINGE ON MY HAND. PT STATED DID NOT FEEL THE FLUID GO IN. PROVIDER NOTIFIED AND OK TO REPEAT PER HER.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Pain and continuous swelling starting from time of administration till 11/5.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Lethargy, Vomiting
Clinical narrative: Extreme lethargy. Headache, chills, emesis.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt received Flu vaccine at clinic at approximately 330 on 11/1/18.  Pt's father pt starting with hives around her face around 6-7 pm that evening.  They gave her Benadryl that did not help resolve hives.  Per pt's father they took her to the Emergency room on 11/3/18 around 8 pm as hives were all over her body and not resolving.  ER provider assessed patient and was sent home with a course of steroids.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Influenza like illness, Lethargy, Nausea
Clinical narrative: With 24 hrs, I had nausea, diarrhea, lethargy, headache and generalized flu like symptoms which lasted for 10 plus/- days. A couple of weeks later, I began getting random "pox-like" eruptions over my body and particularly on my face. The eruptions are fewer now but I still am getting them on my face 2 1/2 months later. They are unsightly and look like a "chicken pox."
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: With 24 hrs, I had nausea, diarrhea, lethargy, headache and generalized flu like symptoms which lasted for 10 plus/- days. A couple of weeks later, I began getting random "pox-like" eruptions over my body and particularly on my face. The eruptions are fewer now but I still am getting them on my face 2 1/2 months later. They are unsightly and look like a "chicken pox."
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pallor, Injection site reaction, Injection site swelling
Clinical narrative: I received the PNEUMOVAX 23 vaccination in the left deltoid on October 5, 2018. The reaction started at around 3 pm with swelling and tightness and pain with redness around the site. It was very painful about a 7-8 on a 0-10 pain scale. The next day the redness had spread completely down my upper arm following my bicep and deltoid muscles. The site was swollen and white.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Skin tightness
Clinical narrative: I received the PNEUMOVAX 23 vaccination in the left deltoid on October 5, 2018. The reaction started at around 3 pm with swelling and tightness and pain with redness around the site. It was very painful about a 7-8 on a 0-10 pain scale. The next day the redness had spread completely down my upper arm following my bicep and deltoid muscles. The site was swollen and white.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Fever, headache, shivers, upset stomach, nauseous, Red hot arm at injection site, approx entire upper arm. Continue spreading to inside arm. Some pain and tenderness. Itching towards end of reaction. Started on 10/24 and continued to 11/1.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pruritus, Pyrexia, Tenderness
Clinical narrative: Fever, headache, shivers, upset stomach, nauseous, Red hot arm at injection site, approx entire upper arm. Continue spreading to inside arm. Some pain and tenderness. Itching towards end of reaction. Started on 10/24 and continued to 11/1.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-JUN-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number ZA72G, expiry date May 2019), (batch number 52B5N ?, expiry date May 2019) and (batch number 5FRCW ?, expiry date May 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated, an employee experienced a rather severe site reaction following administration of FLULAVAL. The healthcare professional did not have any additional information regarding the patients involved or the reaction. The reporter provided 3 lot numbers but unsure which ones might have been used 52B5N, 5FRCW, and ZA72G with expiration date of May 2019. The healthcare professional suggested she will gather additional information and requested to be contacted at a later time by Safety Department. The reported batch number 52B5N and 5FRCW for FLULAVAL QUADRIVALENT 2018-2019 season does not exist in sales database. This case has been linked with case US2018GSK193646, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received SHINGRIX (batch number T5242, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 11th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX which led to incomplete course of vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 5th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th July 2018, 1 days after receiving SHINGRIX, the patient experienced joint pain and mobility decreased. On an unknown date, the outcome of the joint pain and mobility decreased were recovered/resolved. It was unknown if the reporter considered the joint pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced joint pain and inability to lift her arms. The pharmacist was unsure how long these symptoms lasted, but they had resolved. The pharmacist did not have vaccine information for this adverse event.
Sex: U
Vaccine: DTP
Symptoms: Pain, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 59-year-old patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure, whooping cough and pain were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and pain to be related to DTP vaccine. Additional details were provided as follows: This case was reported by a consumer via Interactive Digital Media. This case was reported by the patient for themselves. The age at vaccination was not reported. The patient had all the available vaccinations when they were kid, including the DPT dosages. Two years before the date of reporting at the age of 59, the patient experienced whooping cough. The patient was under the mistaken impression that being vaccinated as a kid meant was protected for life. This was so not the case. The pain and agony from having whooping cough was far worse than any bout of pneumonia had all their life. The patient asked that all must be re-vaccinated every 10 years and did not put it off, all have no idea that how horrible it was. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for pertussis were not provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Retinal haemorrhage
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of macula lutea hemorrhage in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 30 min after receiving SHINGRIX, the patient experienced macula lutea hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the macula lutea hemorrhage was unknown. It was unknown if the reporter considered the macula lutea hemorrhage to be related to SHINGRIX. Additional details were reported as follows: The patient presented with macular hemorrhage 30 to 40 minutes after receiving a dose of SHINGRIX. The health care professional (HCP) did not have SHINGRIX information, as the vaccine was given at a primary care office. The reporter was not willing to provide patient details. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: Sore arm for 4 days, so severe first night that I couldn't sleep. 36 hours after vaccine: nausea, fatigue, fever, headache. To the point where I couldn't get out of bed for 24 hours. Note: I've never had a vaccine reaction before.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm for 4 days, so severe first night that I couldn't sleep. 36 hours after vaccine: nausea, fatigue, fever, headache. To the point where I couldn't get out of bed for 24 hours. Note: I've never had a vaccine reaction before.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Inflammation, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient received Hepatitis B vaccination 2 days ago then developed blistering and itching to site within 24hours. Three blisters noted, 2 intact and 1 open, mild inflammation noted.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 5 days after treatment, arm swelled, felt very hot, it got worse after 5 days. Patient had to go to md to get steroids and allergy pill because it is severely itchy and hot.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Bladder catheterisation, Blood culture, Body temperature increased, Chest X-ray, Decreased appetite
Clinical narrative: Pt presented to clinic on 10/29/2018, after receiving flu shot on 10/24/2018, with temp of 100.6, decreased appetite and fluid intake and fussiness x 4 days. Tests done in clinic. Rocephin injection given IM in clinic. Pt F/U in clinic on 10/30/2018, doing better.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Hypophagia, Irritability, Urine analysis
Clinical narrative: Pt presented to clinic on 10/29/2018, after receiving flu shot on 10/24/2018, with temp of 100.6, decreased appetite and fluid intake and fussiness x 4 days. Tests done in clinic. Rocephin injection given IM in clinic. Pt F/U in clinic on 10/30/2018, doing better.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Condition aggravated, Feeling abnormal, Lyme disease
Clinical narrative: Patient was given a FLUCELVAX QUADRIVALENT shot on Wednesday October 29th and reported that the next day he felt poorly. He went to the hospital on Saturday November 3rd with an exacerbation of his Lyme disease symptoms.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Electrocardiogram normal, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Day after injection terrible pain in shoulder neck and jaw on left side. Heart attack ruled out. Five days later, pancreatits attack. Seven days later, second pancreatitis attack - worst pain ever!
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in jaw, Pancreatitis, X-ray normal
Clinical narrative: Day after injection terrible pain in shoulder neck and jaw on left side. Heart attack ruled out. Five days later, pancreatits attack. Seven days later, second pancreatitis attack - worst pain ever!
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Gave client the vaccines and about 4-5 minutes later, she became pale, light headed and started vomiting. Put cool cloths on her head and neck areas and gave her water to drink. She said she did eat prior to coming in. Felt better about 20 minutes later. She left with her mother and driver.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt had hives develop to flu shot 2 days after shot was given. The parents called pharmacy, over the weekend, and they informed them to contact us. Per pt's parents, pt is improving with Benadryl and a Oatmeal bath. I informed them to go to urgent care if symptoms get worse.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: GRAPEFRUIT SIZED AREA OF ERYTHEMA TO LEFT LEG AT INJECTION SITE AND LATERAL TO INJECTION SITE. MINIMAL TENDERNESS, NOT WARM TO TOUCH.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Impaired work ability, Nasal congestion, Nausea
Clinical narrative: HEAD TO TOE RED HIVES/RASH (Face, neck, shoulders, chest, back, arms, stomach, buttock, legs, feet). Headache, total body aches, arm pain, total body itching, nausea, stuffed and runny nose, sore throat, fatigue. Missed work, had to pay for doctor visit, had to take additional medications including BENADRYL, ZYRTEC, and prednisone.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Pain, Pruritus generalised, Rash erythematous, Rash generalised
Clinical narrative: HEAD TO TOE RED HIVES/RASH (Face, neck, shoulders, chest, back, arms, stomach, buttock, legs, feet). Headache, total body aches, arm pain, total body itching, nausea, stuffed and runny nose, sore throat, fatigue. Missed work, had to pay for doctor visit, had to take additional medications including BENADRYL, ZYRTEC, and prednisone.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: HEAD TO TOE RED HIVES/RASH (Face, neck, shoulders, chest, back, arms, stomach, buttock, legs, feet). Headache, total body aches, arm pain, total body itching, nausea, stuffed and runny nose, sore throat, fatigue. Missed work, had to pay for doctor visit, had to take additional medications including BENADRYL, ZYRTEC, and prednisone.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 34 year old female patient. Information about medical history, concurrent conditions and concomitant therapies were unknown by reporter. On 19-JUL-2018, the patient was vaccinated with first dose of RECOMBIVAX HB (lot # M040422, expiration date 07-JUL-2019) (route and dose were not reported) for prophylaxis. On 29-AUG-2018, not knowing the patient was two weeks pregnant (vaccine exposure during pregnancy), the patient received the second dose of RECOMBIVAX HB (lot # M040422, expiration date 07-JUL-2019, for prophylaxis; route and dose were not reported). The last menstrual period(LMP) was calculated as 15-AUG-2018 and expected delivery of date(EDD) was calculated as 22-MAY-2019. The treatment was not given for the event. Information about lab diagnostics/studies performed was unknown by reporter. The pregnancy outcome was outcome pending. The fetal outcome was unknown. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a pharmacist administered the ZOSTAVAX (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2014, the patient was treated by a physician for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a physician, recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-SEP-2012, a healthcare provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 24-MAY2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider at a healthcare facility recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2006, a health care provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 25-DEC-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2007, the ZOSTAVAX was administered to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history or concomitant medications. On or about 28-OCT-2016, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-FEB-2018, the patient was treated by a physician at a neurology service for shingles. She was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history or concomitant medications. In 2010, the patient was administered ZOSTAVAX by a physician (dose, route, and lot # not provided). The physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by the same physician for shingles. She was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, MMRV, PNC13, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. The patient concomitant therapy included ferrous sulfate. The patient did not have any pertinent medical history and any drug reactions or allergies. On 13-SEP-2018, the patient was vaccinated with M-M-R II, diphtheria toxoid (+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid; VAQTA, LIQUID PEDVAXHIB, PREVNAR 13, VARIVAX, PROQUAD (dose, dose number, site and route of administration, lot # and expiration date were not reported for all of them) for routine vaccinations. Subsequently on 14-SEP-2018, the patient experienced pyrexia, diarrhoea and vomiting. The patient had office visit. A treatment was given (unspecified) for the events. No laboratory diagnostics or studies was performed. The outcome of pyrexia, diarrhoea and vomiting was unknown. The relatedness between the events and the suspect vaccines were not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. 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 subcutaneously vaccinated with an improperly stored dose of VARIVAX lot # M048203, expiration date 07-DEC-2018 (dose and route of administration were not reported). There was no adverse effect reported.  Administered dose of vaccine experienced the temperature excursion between -14 to -10 (also reported as -9.6) degrees Celsius for 93 hours and 45 minutes. Data logger was involved. The vaccine underwent previous excursion reported between -14 to -10 degrees Celsius for 2 hours. No product quality complaint (PQC) was involved.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 78-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 22nd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX and an unknown time after starting VALTREX, the patient experienced rash. The patient was treated with VALTREX. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on left arm. The reporter stated that, the patient experienced a rash on the left side of her chin after receiving the SHINGRIX vaccine. The patient called her doctor in regards to the situation, and was then prescribed with VALTREX. The patient took one dose and then the rash cleared up. The pharmacist did not know if a definitive diagnosis for Shingles was made or not. No further details were provided by the pharmacist.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of febrile seizure in a 4-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 4H5PT, expiry date 30th June 2019) for prophylaxis. On 26th October 2018 11:00, the patient received FLUARIX QUADRIVALENT 2018-2019 season .5 ml. On 26th October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced fever. On 26th October 2018 01:15, 2 hours 15 minutes after FLUARIX QUADRIVALENT 2018-2019 season,the patient experienced febrile seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile seizure and fever were unknown. It was unknown if the reporter considered the febrile seizure and fever to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient was well prior to the vaccination. The patient was vaccinated on the morning of reporting date. The patient's mother called the office at 1:30 pm to report the seizure. A fever was also present. The patient was taken to the emergency room and was admitted for overnight observation.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Feeling hot, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 67-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 30th March 2018). On 15th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, 7 days after receiving SHINGRIX, the patient experienced vesicular rash and discomfort. On an unknown date, the patient experienced feeling of warmth. On an unknown date, the outcome of the vesicular rash and discomfort were not recovered/not resolved and the outcome of the feeling of warmth was not reported. It was unknown if the reporter considered the vesicular rash, discomfort and feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a shingles type of reaction under the skin by the area on the rib cage after the 2 doses of SHINGRIX. The reaction was reported as rash and discomfort that goes away and comes back as well as less than a year after receiving SHINGRIX, the patient experienced warm feeling in the same place. The patient stated the reaction started about a week after the 2nd dose. This had not been diagnosed till the time of reporting by a physician.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest pain, Mobility decreased, Nausea, Viral upper respiratory tract infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 58-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 16th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced nausea and weakness. On 23rd October 2018, the patient experienced chest pain and viral upper respiratory tract infection. On an unknown date, the outcome of the nausea and weakness were not recovered/not resolved and the outcome of the chest pain and viral upper respiratory tract infection were unknown. It was unknown if the reporter considered the nausea, chest pain, viral upper respiratory tract infection and weakness to be related to SHINGRIX. Additional details reported as follows: The patient's husband was pharmacist and he administered a dose of SHINGRIX to the patient at their home. The day after the vaccination, the patient experienced nausea and weakness. The patient had difficulty to getting out of bed. The patient went to a physician and diagnosed with a viral upper respiratory tract infection. The patient had denied permission to contact their physician. This case has been linked with case US2018195931 (vaccinated with same lot number and expiry date), reported by the same reporter.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 58-year-old male patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 16th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced nausea and weakness. On an unknown date, the outcome of the nausea and weakness were recovered/resolved. It was unknown if the reporter considered the nausea and weakness to be related to SHINGRIX. Additional details reported as follows: This case was reported by the patient's wife. The patient was a pharmacist, who received a dose of SHINGRIX to himself at home. The day after the vaccination, the patient experienced nausea and weakness. In October 2018, 5 days later the events were resolved. The patient had denied permission to contact their physician. This case has been linked with case US2018195930 (vaccinated with same lot number and expiry date), reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number ZA72G, expiry date May 2019), (batch number 52B5N ?, expiry date May 2019) and (batch number 5FRCW ?, expiry date May 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated, an employee experienced a rather severe site reaction following administration of FLULAVAL. The healthcare professional did not have any additional information regarding the patients involved or the reaction. The reporter provided 3 lot numbers but unsure which ones might have been used 52B5N, 5FRCW, and ZA72G with expiration date of May 2019. The healthcare professional suggested she will gather additional information and requested to be contacted at a later time by Safety Department. The reported batch number 52B5N and 5FRCW for FLULAVAL QUADRIVALENT 2018-2019 season does not exist in sales database. This case has been linked with case US2018182650, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of muscle pain in a adult 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 year after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient presented with severe muscle pain for 5 to 6 months followed by a dose of SHINGRIX. The patient felt like muscle was tearing with arm movement. The patient received 2nd dose of SHINGRIX vaccine with no issues. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Last week from the reporting date, the patient came to the reporter's office presenting with a rash. The patient was diagnosed with a mild case of Shingles. This case was considered as suspected vaccination failure as the exact time to onset for the event and lab test confirmation for targeted disease were unknown.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 72-year-old male patient received PREVNAR 13, (lot no: S74425, expiration date: Dec2019, NDC number: 00005197102), intramuscular on 22Oct2018 at 0.5 ml, single for immunisation. Medical history included pneumonia in the past so he was getting his pneumonia shot. The patient's concomitant medications were not reported. On 24Oct2018, the broke out like a rash all over with itching it was a like fine little light small slightly red little bumps. He is probably 6 foot, 253 pounds something like that. It was further stated that the patient picked up the BENADRYL to take by mouth because it was all over his body. The reporter considered the event to be related to PREVNAR 13. The patient had not recovered from the event.