chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 October 2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about October 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: M
Vaccine: FLUN4
Symptoms: Rhinorrhoea
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received FLUMIST QUADRIVALENT (intranasal) 0.2 ml unknown, via nasal route, on an unknown date. On an unknown date, the patient experienced sniffles. Treatment with FLUMIST QUADRIVALENT (intranasal) was not changed. The outcome of the event was unknown. The event was considered non-serious.
Sex: U
Vaccine: TDAP
Symptoms: Autoimmune disorder, Psoriasis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of psoriasis in a patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced psoriasis. On an unknown date, the outcome of the psoriasis was unknown. It was unknown if the reporter considered the psoriasis to be related to dTpa vaccine. Additional information received as follows: The age at vaccination was not reported. The patient reported that vaccine gave his/her psoriasis, an autoimmune disease. It was much more than just skin issues. The vaccine was combined with the Tetanus vaccine. The patient would never get a vaccine again.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were received as follows: The age at vaccination was not reported. The patient did not want to vaccinated by the Flu vaccine. The patient was vaccinated in 2017 and she was 3 weeks in bed. This case was considered as suspected vaccination failure case since the exact time to onset and laboratory test confirmation were unknown at the time reporting.
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nasopharyngitis, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via social media interactive digital media and described the occurrence of vaccination failure in a adult patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), cold and sickness. On an unknown date, the outcome of the vaccination failure, whooping cough, cold and sickness were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough, cold and sickness to be related to DTPa vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported she had the whooping cough vaccination when she was a child and had whooping cough as an adult. The physician said it was just a cold not to come in or worry. She was extremely sick and probably should have been in the hospital. This case was considered as suspected vaccination failure as a primary vaccination schedule, TTO (time to onset) of event whooping cough and laboratory confirmation test were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The consumer stated that she received Shingles vaccine and experienced some potential adverse event. When the patient was noticed a call, the patient ended the call abruptly and did not provide any additional details.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pruritus, Pyrexia, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 24th October 2018, the patient received SHINGRIX. On 25th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever and malaise. On 27th October 2018, the patient experienced pruritus. On 29th October 2018, the patient experienced rash. On an unknown date, the outcome of the fever and malaise were recovered/resolved and the outcome of the pruritus and rash were unknown. It was unknown if the reporter considered the fever, malaise, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the right deltoid. The patient developed a fever and malaise the day after receiving the SHINGRIX vaccine. Three days later, the patient developed itching in the left scapula area and the left chest area. Two days after the itching a rash developed. A few days ago, the patient developed bumps in the right inguinal region. The patient gave consent to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Valacyclovir, Omega 3, Vitamin D3 and Progesterone Cream. On 14th November 2018, the patient received SHINGRIX (intramuscular). On 14th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The batch number for SHINGRIX was not reported. The patient took Estrogen cream and Bioidentical hormones as a concomitant medications. The patient had planned to follow-up with her physician on an unknown date. The reporter consented to follow-up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included antihistamine for an unknown indication. On 12th November 2018, the patient received the 2nd dose of SHINGRIX 50 µg. In November 2018, the patient started antihistamine at an unknown dose and frequency. On 12th November 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site itching and numbness of upper extremities. In November 2018, the patient experienced nausea and sleep disturbance. In November 2018, the outcome of the numbness of upper extremities was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site itching and nausea were not recovered/not resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site itching, numbness of upper extremities, nausea and sleep disturbance to be related to SHINGRIX. Additional details were reported as follows: The patient had the 2nd dose of SHINGRIX on Monday (12th November 2018) afternoon and that evening she started developing pain, redness, swelling and itching at the injection site. The pain woke her up in the night. The patient arm also felt numb and she was a little nauseous. The patient saw her healthcare professional (HCP) and was told to take an antihistamine. The symptoms have gotten worse today on 16th November 2018, except for numbness, which had resolved.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Nausea, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included antihistamine for an unknown indication. On 12th November 2018, the patient received the 2nd dose of SHINGRIX 50 µg. In November 2018, the patient started antihistamine at an unknown dose and frequency. On 12th November 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site itching and numbness of upper extremities. In November 2018, the patient experienced nausea and sleep disturbance. In November 2018, the outcome of the numbness of upper extremities was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site itching and nausea were not recovered/not resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site itching, numbness of upper extremities, nausea and sleep disturbance to be related to SHINGRIX. Additional details were reported as follows: The patient had the 2nd dose of SHINGRIX on Monday (12th November 2018) afternoon and that evening she started developing pain, redness, swelling and itching at the injection site. The pain woke her up in the night. The patient arm also felt numb and she was a little nauseous. The patient saw her healthcare professional (HCP) and was told to take an antihistamine. The symptoms have gotten worse today on 16th November 2018, except for numbness, which had resolved.
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 4-year-old female patient who received INFANRIX (batch number 2N43Z, expiry date 12th April 2020) for prophylaxis. On an unknown date, the patient received the 3rd dose of INFANRIX. On 14th November 2018, unknown after receiving INFANRIX, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient had redness and swelling around 5cm in size.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental underdose, Injection site reaction, Skin infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin infection in a 35-year-old female patient who received FLUARIX QUADRIVALENT (batch number AL545, expiry date 30th June 2019) for prophylaxis. On 3rd November 2018, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 3rd November 2018, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced accidental underdose. In November 2018, the patient experienced skin infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the skin infection and accidental underdose were unknown. It was unknown if the reporter considered the skin infection to be related to FLUARIX QUADRIVALENT. Additional information received as follows: The patient developed localized skin infection at the site of injection. On 5th November 2018, the patient came in with an antibiotic prescription. During the administration of the vaccine some of the vaccine had come out during administration and did not receive the entire dose, which led to accidental underdose. The patient's physician suggested that she should get the vaccine again. The pharmacist concern was whether the patient should be revaccinated or not. Emergency room visit was required. No further details were provided. Transferred call to medication information for further details.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 17th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills, fever, stiff neck, pain in arm, malaise, sleeplessness and feels awful were recovered/resolved and the outcome of the back pain and tiredness were recovering/resolving and the outcome of the heaviness in arm was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm to be related to SHINGRIX. Additional information received as follows: The retired pediatrician reported the case for herself. Around 10 am, the patient received SHINGRIX on the left arm. The patient experienced flu like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, muscle aches, uncontrolled shivering, neck stiffness, tiredness, sore and achy arm, so much malaise and she could not sleep. The patient felt awful. These symptoms put her in bed. She took TYLENOL. Till the reporting day, she was tired and had back pain but it was much better. Her arm felt heavy but did not hurt. The patient's other symptoms had resolved. Lot number and expiration date was not available. The patient gave consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Insomnia, Limb discomfort, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 17th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills, fever, stiff neck, pain in arm, malaise, sleeplessness and feels awful were recovered/resolved and the outcome of the back pain and tiredness were recovering/resolving and the outcome of the heaviness in arm was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm to be related to SHINGRIX. Additional information received as follows: The retired pediatrician reported the case for herself. Around 10 am, the patient received SHINGRIX on the left arm. The patient experienced flu like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, muscle aches, uncontrolled shivering, neck stiffness, tiredness, sore and achy arm, so much malaise and she could not sleep. The patient felt awful. These symptoms put her in bed. She took TYLENOL. Till the reporting day, she was tired and had back pain but it was much better. Her arm felt heavy but did not hurt. The patient's other symptoms had resolved. Lot number and expiration date was not available. The patient gave consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 17th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills, fever, stiff neck, pain in arm, malaise, sleeplessness and feels awful were recovered/resolved and the outcome of the back pain and tiredness were recovering/resolving and the outcome of the heaviness in arm was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, stiff neck, tiredness, pain in arm, malaise, sleeplessness, feels awful and heaviness in arm to be related to SHINGRIX. Additional information received as follows: The retired pediatrician reported the case for herself. Around 10 am, the patient received SHINGRIX on the left arm. The patient experienced flu like symptoms, joint pain, muscle pain, headache, back pain, chills, fever, muscle aches, uncontrolled shivering, neck stiffness, tiredness, sore and achy arm, so much malaise and she could not sleep. The patient felt awful. These symptoms put her in bed. She took TYLENOL. Till the reporting day, she was tired and had back pain but it was much better. Her arm felt heavy but did not hurt. The patient's other symptoms had resolved. Lot number and expiration date was not available. The patient gave consent to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The reporter's husband received SHINGRIX on an unknown arm. The reporter also reported that, the patient experienced soreness in his arm which resolved after receiving the vaccine in 2 to 3 days. The patient had been unable to secure the 2nd dose due to availability of the product. The reporter consented to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling abnormal, Malaise, Pain
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 74 years old female patient who experienced ache, diarrhea, sickness and feeling lousy, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Chemotherapy in 2012 and 2013. The patient's past medical treatment(s), vaccination(s) and family history were not provided. In 2015, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported). On an unknown date, the patient developed a non-serious achy, diarrhea, very sick and feeling lousy (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was illness, sickness, diarrhea and ache. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for all the events. List of document held by sender: None.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist via other company (Pfizer). This case involves a 77 years old female patient who experienced allergic reaction to tetanus shot- rash all over herself, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Penicillin and Niacin allergy. On an unknown date in year 2012, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic reaction to tetanus shot- rash all over herself (rash generalised) with unknown latency following the administration of TETANUS TOXOID. Lab data was not provided. Final diagnosis was allergic reaction to tetanus shot- rash all over herself. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, IPV, MENB, MMR, MNQ, VARCEL
Symptoms: Expired product administered
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 16 year old female patient who was vaccinated with 0.5 ml first dose of MENACTRA (Batch number: U5751AB, expiration date: 12-Nov-2018, route and site of administration was not reported) on 16-Nov-2018. The patients medical history was not reported. Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; POLIO VACCINE INACT (IPV) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS B VACCINE (HEP-B-VAX) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACC.) for Immunisation; BEXSERO for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. 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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue, Wrong technique in product usage process
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who supposed to vaccinated with a 0.5 ml  second dose of PENTACEL (lot C5422AA and Exp. Date not reported) via unknown route in the left thigh on 28-Nov-2018. The patient's medical history and concomitant medications were not reported. It was reported that, gave the clear liquid portion of the PENTACEL vaccine without the powder. It was an actual medication error due to wrong injection technique. No any information reported whether patient experienced any 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: 85.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Injection site discolouration, Injection site nodule, Injection site reaction, Skin exfoliation
Clinical narrative: PEA-SIZED MILDLY HYPERPIGMENTED AREA WITH DIME SIZED KNOT UNDERNEATH TO RIGHT LOWER THIGH NOTICED THE DAY OF INJECTION PER MOTHER. MOTHER STATES THAT THE DISOLORATION AND KNOT HAS NOT CHANGED IN SIZE BUT DID PEEL AT ONE TIME.  WAS ADVISED INITIALLY TO APPLY WARM COMPRESSES TO THE AREA AND MASSAGE WITH NO CHANGE. PT SEEN IN CLINIC 11/26/2018 WITH NO CHANGE AND INSTRUCTED TO MONITOR FOR ANY CHANGES AND REPORT.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Pain and stiffness in joints, stiff neck, muscle and body aches x 1 week.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE SWOLLEN/HARD, PAINFUL, WARM TO THE TOUCH.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt woke up with hives the next morning after the 2nd dose in the series only.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia, Walking aid user
Clinical narrative: Developed Guillain-Barre Syndrome. Hospitalized on 8/30/2018. Treated with IVIG. Currently completing a course of biweekly IVIG and is gradually improving. Ambulating with a cane and experiencing decreased paresthesias.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient rec'd the shot on 11/27. When patient woke up the next morning (11/28) she complained of a swollen arm. I only noticed it around the injection shot. After school around 4pm she complained of it being itchy all day. We noticed around 6pm that her arm was swollen from her shoulder to elbow and was red. We contacted pharmacy as well as her PCP. Her PCP recommended 25mg of BENADRYL. We gave this to her then she went to bed. The morning of 11/29 the swelling was once again around the injection area. She still complained of her arm being itchy. She took another 25mg the night of 11/29. The morning of 11/30 the swelling was almost gone.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered a 3 years and older Influenza vaccine when a 6-35 months Influenza was indicated for usage.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Brachial plexopathy, Electromyogram, Nuclear magnetic resonance imaging
Clinical narrative: Per employee's incident report: "There is a temporal relationship between the and the onset of a right-sided brachial plexitis. This should result in minimum with a report to the CDC on adverse vaccine events. With luck, there will not be sequel, although there have been some medical expenses. I have not investigated with vaccine compensation act deals with this and do not think I should be responsible both to make that report and are not going to investigate whether I am entitled to compensation to cover my medical expenses, then I would appreciate being informed. I did ask others to make this report but had been told it was not already reported. There does not seem to be another place to write the symptoms and occurrence. It began 2 weeks after the event, I had no way of appreciating that the symptoms were accessible and were related to the vaccine which had been 2 weeks earlier. Thus when I called Dr. with the symptoms, he wanted an MRI before he saw me, then saw me the next day in office. He requested more MRI's a couple days later. He wanted follow with an EMG at the appropriate time 3 weeks after the onset of symptoms and then got a second opinion. I don't see how employee would have had the expertise in this and don't feel that I should contact employee health even when I pointed out there was a temporal relationship."
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: QUARTER SIZE RED AREA X 5 DAYS.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, fever lasting 36 hours, muscle aches lasting over 48 hours. Similar effects after first dose on 8/10 but shorter duration. Though these are listed as side affects, I have never suffered  from side affects after an inoculation before so I thought it was worth reporting.
Age: 20.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Headaches-lasted 4 hours. Vomiting/nausea-lasted 6 hours. Dizziness- lasted 14 hours.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain initially, progressed to shooting pain, limited mobility.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster oticus
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 21-APR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered shingles in ear, Bell's palsy, and Ramsay Hunt syndrome. As a direct and proximate result of defective ZOSTAVAX, patients symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review, Bell's palsy and shingles in ear/Ramsay Hunt syndrome were determined significant medical event. Bell's palsy and shingles in ear/Ramsay Hunt syndrome were considered disabling. 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 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 07-NOV-2014, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 29-OCT-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: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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. In 2015, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, 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, 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. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. 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 09-MAY-2013, a physician administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 08-FEB-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, 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, 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. The outcome of the events is unknown. The causality of the events is related. 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 an unknown date in 2012, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 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: 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 providers 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 09-MAR-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2013, 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 (dates unknown), 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.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swelling to site apx. 1inch x 1.5 inch.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Hypophagia, Injection site swelling, Lymphadenopathy
Clinical narrative: Within a few hours I felt nauseous. By the next morning my arm at the injection site was swollen and the armpit (gland) was swollen on the same arm. I was nauseous and didn't eat much for several days. I felt like I had been hit by a truck, felt very achy and weak. By the third day I realized I probably had a reaction to the shot and let my doctor know the symptoms and effects. It was a week before I began feeling better.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Within a few hours I felt nauseous. By the next morning my arm at the injection site was swollen and the armpit (gland) was swollen on the same arm. I was nauseous and didn't eat much for several days. I felt like I had been hit by a truck, felt very achy and weak. By the third day I realized I probably had a reaction to the shot and let my doctor know the symptoms and effects. It was a week before I began feeling better.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient states left arm (at injection site) is swollen, red, large. Approximately 3" down and 5" across..she has no problem breathing.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Generalized hives. Redness warmth and swelling at injection site. Required IM dose DECADRON and oral BENADRYL.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Skin lesion, Vulvovaginal pruritus
Clinical narrative: The patient started with vaginal itching, then she developed many round lesions on both legs that range in size from pennies to the size of a quarter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia
Clinical narrative: Extremely sore arm at the injection site for approximately 72 hours. So much so that it was difficult to sleep at night.
Age: 81.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Hematoma at injection site.
Age: 77.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash pruritic
Clinical narrative: DELAYED LOCALIZED ITCHY RASH ON LEFT UPPER ARM.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: FEVER.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Tenderness
Clinical narrative: Large area of erythema and tenderness on left arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site induration, Injection site swelling
Clinical narrative: Patient came in to pharmacy on November 30th around 3pm to state her arm was swollen and hard feeling where the injection was given. She has use of her arm and no issues only painful if pressed on it and skin discolortion. She is going to MD appt on Friday Dec 7th and has not seen a doctor yet due to her traveling for vacation.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pruritus, Skin warm
Clinical narrative: PATIENT HAD REDNESS AND HEAT IN THE LEFT ARM FROM THE APROXIMATE SITE OF THE INJECTION AND EXTENDING ABOUT 6 INCHES DOWN AND ABOUT 3/4 OF THE WAY WRAPPED AROUND HER ARM.  PATIENT SAID IT WAS HOT AND ITCHY. THIS REACTION BEGAN ABOUT 2 DAYS AFTER HER INJECTION.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Muscular weakness, Myalgia
Clinical narrative: Pt states that she is having muscle weakness/pain and difficulty breathing since the day after the administration, starting 11/27.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Pt stated few hours after vaccine she started to fee feverish, had aches and pains and broke out into hives. She took TYLENOL OTC and rested for few days and felt better after that, no medical attention.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness and swelling at the injection site, muscle pain, tiredness, headache. Lasted 4 days and then came down with bronchitis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Pain, redness and swelling at the injection site, muscle pain, tiredness, headache. Lasted 4 days and then came down with bronchitis.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain
Clinical narrative: Soreness at injection site as well as "neck pain"... pt thought injection was "too high on arm".
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site rash
Clinical narrative: 1-2" rash surrounding injection site.