chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the physician administered flu shot to many patients and experienced side effects from the flu shot. The reporter stated that the physician found out there was something bad in the formulation that she was administering, something like formaldehyde. The reporter stated that the physician ordered the flu shots that were made in specific countries and this formulation did not contain any of the other ingredients (just the flu strains).   The reporter stated that at the time of reporting the this formulation was administered none of the flu shot patients got any side effects any from the flu shot any more. This case has been linked with case US2019221818, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: developed "flu-like" symptom."fo. u few days post vaccination; sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. A year before the time of reporting, the patient received a dose of Shingrix. The patient experienced sore arm and in addition he developed flu like symptoms for a few days post vaccination. The reporter declined to provide the physician demographics. No additional adverse event information was given. This case has been linked to US2019AMR222413 (wife's case), reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported, however it could be over 50 years. The reporter stated that the patient had pain at injection site after vaccination. The patient refused second dose due to the adverse event. This case has been linked to US2019AMR222641, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: acute disseminated encephalomyelitis; This case was reported by a lawyer and described the occurrence of acute disseminated encephalomyelitis in a adult patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced acute disseminated encephalomyelitis (serious criteria GSK medically significant). On an unknown date, the outcome of the acute disseminated encephalomyelitis was unknown.   It was unknown if the reporter considered the acute disseminated encephalomyelitis to be related to Shingrix.  Additional details were provided as follow: The initial information received on 04 December 2019 via legal complaint. The age group was selected as adult as per vaccine indication. As per attorney, indicating he has a client who experienced acute disseminated encephalomyelitis (ADEM) an unspecified amount of time after receiving Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash/ rash on back around belt; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient developed a rash on back around belt line after receiving Shingrix. The reporter did not consent to follow-up. No patient data given other than the healthcare professional (HCP) was a relative.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: fatigue; injection site pain; arm soreness / arm pain; muscle aches; nausea; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering. On an unknown date, the outcome of the fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering were recovered/resolved.   It was unknown if the reporter considered the fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix approximately 3 months ago from the date of reporting, specific date unknown. The day after vaccination, the patient reported that experienced arm pain, arm soreness, fatigue, headache, muscle aches, and nausea. Till the time of reporting, symptoms are resolved. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: fatigue; injection site pain; arm soreness / arm pain; muscle aches; nausea; headache; shivering; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering. On an unknown date, the outcome of the fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering were recovered/resolved.   It was unknown if the reporter considered the fatigue, injection site pain, pain in arm, muscle pain, nausea, headache and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix approximately 3 months ago from the date of reporting, specific date unknown. The day after vaccination, the patient reported that experienced arm pain, arm soreness, fatigue, headache, muscle aches, and nausea. Till the time of reporting, symptoms are resolved. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Erythema, Feeling abnormal, Hypertension, Nausea
Clinical narrative: anaphylaxis; restless; red skin; swelling; nausea; fever; high blood pressure; Heart racing; tachycardia; feeling bad; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), restlessness, skin red, swelling, nausea, fever, blood pressure high, heart racing, tachycardia and feeling bad. The patient was treated with acetylsalicylic acid (Aspirin) and metoprolol tartrate (Lopressor). On an unknown date, the outcome of the anaphylaxis, restlessness, skin red, swelling, nausea, fever and blood pressure high were recovered/resolved and the outcome of the heart racing, tachycardia and feeling bad were unknown.   It was unknown if the reporter considered the anaphylaxis, restlessness, skin red, swelling, nausea, fever, blood pressure high, heart racing, tachycardia and feeling bad to be related to Shingrix.  Additional details were provided as follows:  By the evening of vaccination, she was feeling very restless.  The skin on her head turned bright red and was swollen and she could feel her heart beating like crazy.  The patient's heart was going into tachycardia.  She started getting nauseated and had a fever.  The patient took some Aspirin and slept that night, but she was still feeling bad on 24th October 2019.  The patient finally went to the emergency room around 4 PM and her heart was racing and her blood pressure was very elevated.  She said it was anaphylaxis.  She was given Lopressor IV push and stayed at the emergency room for about 6 hours before going home. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia, Restlessness, Swelling, Tachycardia
Clinical narrative: anaphylaxis; restless; red skin; swelling; nausea; fever; high blood pressure; Heart racing; tachycardia; feeling bad; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), restlessness, skin red, swelling, nausea, fever, blood pressure high, heart racing, tachycardia and feeling bad. The patient was treated with acetylsalicylic acid (Aspirin) and metoprolol tartrate (Lopressor). On an unknown date, the outcome of the anaphylaxis, restlessness, skin red, swelling, nausea, fever and blood pressure high were recovered/resolved and the outcome of the heart racing, tachycardia and feeling bad were unknown.   It was unknown if the reporter considered the anaphylaxis, restlessness, skin red, swelling, nausea, fever, blood pressure high, heart racing, tachycardia and feeling bad to be related to Shingrix.  Additional details were provided as follows:  By the evening of vaccination, she was feeling very restless.  The skin on her head turned bright red and was swollen and she could feel her heart beating like crazy.  The patient's heart was going into tachycardia.  She started getting nauseated and had a fever.  The patient took some Aspirin and slept that night, but she was still feeling bad on 24th October 2019.  The patient finally went to the emergency room around 4 PM and her heart was racing and her blood pressure was very elevated.  She said it was anaphylaxis.  She was given Lopressor IV push and stayed at the emergency room for about 6 hours before going home. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and had fever and shivering that lasted for 3 days. The reporter did not consent to follow up. This case was 2 of 3 linked cases.
Sex: F
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the physician received flu shot herself and experienced side effects from the flu shot. The reporter stated that the physician found out there was something bad in the formulation that she was administering, something like formaldehyde. The reporter stated that the physician ordered the flu shots that were made in specific countries and this formulation did not contain any of the other ingredients (just the flu strains).   The reporter stated that at the time of reporting this formulation was administered none of the flu shot patient got any side effects any from the flu shot any more. The reporter herself has never received a flu shot. This case has been linked to US2019AMR222423, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Keratitis
Clinical narrative: keratitis; This case was reported by a pharmacist via call center representative and described the occurrence of keratitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced keratitis. On an unknown date, the outcome of the keratitis was unknown.   It was unknown if the reporter considered the keratitis to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. It was reported that the patient experienced keratitis, after receiving Shingrix. The patient details, expiration date, batch number, first dose of Shingrix and onset of the adverse event were not provided. The reporter consented to follow up.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Face was swollen; Itching and had hives on different locations on her body; Itching and had hives on different locations on her body; This is a spontaneous case, initially received from other non-health professional via Communications (reference number: SEQ19-07176) on 02-Dec-2019, concerning an 8-year-old female patient.   The patient's relevant medical history includes penicillin allergy and allergy to ibuprofen, both caused a small rash.  The patient didn't have any concomitant medications.  On 23-Nov-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location:  left deltoid, batch number and expiration date: not reported] for influenza prophylaxis.   On 24-Nov-2019, the patient experienced itching and had hives on different locations on her body. The patient was treated with Allegra (fexofenadine hydrochloride) and Benadryl (diphenhydramine hydrochloride), at unspecified dose, route of administration and frequency.  The hives cleared but her face was swollen.  On 26-Nov-2019, the patient was taken to urgent care and was given prednisone and told to continue the Allegra and Benadryl. She was given a prescription for an Epipen (epinephrine).  On 29-Nov-2019, the outcome of swelling face and itching were resolved.  The reporter assessed the case as serious but did not provide causality assessment.  The case was linked with 201907059 (due to same reporter).  Company Comment: The patient experienced swelling face, urticaria and pruritus one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. Reportedly, the patient didn't take concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced swelling face, urticaria and pruritus one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. Reportedly, the patient didn't take concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Paraesthesia
Clinical narrative: Arm numbness at and around the site of the injection; Tingling of arm; This is a spontaneous case, initially received from other health professional via agency (reference number: SEQ19-07201) on 03-Dec-2019, concerning a 46-year-old, male patient.   The patient's medical history was not reported.   The concomitant medications of the patient included hydrochlorothiazide, rosuvastatin, amlodipine and unspecified multivitamins for an unknown indication.   On 15-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P100110961 and expiration date: 23-May-2020] for prevention of seasonal influenza.   On the same day, the patient experienced numbness at and around the site of injection and tingling of arm. No treatment measures were taken.  At the time of initial reporting, the patient was not recovered from numbness at and around the injection site, while the outcome of arm tingling was not reported.  The events were considered serious per reporter. The reporter did not provide causality assessment to Afluria Quadrivalent.  Company Comment: The patient experienced hypoaesthesia and paraesthesia on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Multiple concomitant medications may have contributed to development of the events. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced hypoaesthesia and paraesthesia on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Multiple concomitant medications may have contributed to development of the events. No medical history and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Myalgia Acetaminophen 650 mg QID take two tablets by mouth every 6 hours as needed for mild pain, fever, or headache, diphenhydramine 100 mg qid take two capsules by mouth every 6 hours hold cetirizine while on diphenhydramine
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Myalgia
Clinical narrative: Myalgia & chills
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Irritability
Clinical narrative: fussiness for 8 hours
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Shot given on Friday, started to get sore Friday night, on Saturday it became pretty painful and by Sunday it was swollen, red, inflamed and itching from right shoulder to right wrist.  On Monday it began to subside and got better each day.  Today just slight redness in upper arm.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Peripheral swelling, Pruritus
Clinical narrative: Shot given on Friday, started to get sore Friday night, on Saturday it became pretty painful and by Sunday it was swollen, red, inflamed and itching from right shoulder to right wrist.  On Monday it began to subside and got better each day.  Today just slight redness in upper arm.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Route was intended to be IM.  Upon assessment by this RN, injection was given below deltoid.  Employee (patient) reports needle had been inserted one half or less by staff member, then injected.  Appears to have been administered SQ.  Employee (patient) reports swelling, pruritis,  and erythema to injection site.  Reported to this RN 12/11/2019 at 0930.  Denies any worsening of symptoms since increased erythema early this morning.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: L arm tingling onset x 5 mins after immunization, still present 1.5 hours later
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Throat irritation
Clinical narrative: Client had identified as dermatological contact latex allergy. Client described a localized hive reaction  to band aid in the past @~11:15 adult dose hepatitis A vaccine admin. by R.N.  12:06 Client described slight itching feeling in throat. Denied itching or difficulty breathing or nausea. Visual skin exam no  blotchy appearance, no appearance of hives or redness, B/P 138/78, HR 88 this writer administered 50mg diphenhydramine oral. Client remained seated for continued monitoring.  12:24 Skin assess: no hives visible, no blotching or redness. Client denied nausea, no change in throat itching. Denied any mucos membrane itching B/P 142/82 HR 76. __Client recalls and reports experiencing throat itching in the past after latex exposure. Denied any medical intervention necessary at the time.  12:42 Skin assess: no visible hives, no blotchy or redness. Client denies nausea and reported throat itching had ceased. Denied any mucous membrane itching.  B/P 140/78 HR 75.  36 minutes had elapsed since admin. of 50 mg of diphenhydramine, throat itching had ceased vital signs remained stable, skin assess without hives, redness, blotching. No nausea or lightheadedness. Client denied any feelings of illness or breathing difficulties. Client counseled on additional dose of diphenhyramine 6 p.m. Counseled client and supervisor on s/s of allergic reaction and proper response actions.  Client remained at worksite, supervisor was onsite and aware of incident and intervention.   17:30 Client remained at work site without any indications of distress or illness, as witnessed by RN
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Immediate post-injection reaction
Clinical narrative: she was very tired" and patient was "immediately tired"; This spontaneous report was received from an office manager via company representative and refers to a 16-year-old female patient. Her concurrent condition included no allergies to drugs. The patient did not take any concomitant medication. There was no information about the patient's medical history provided.   On 11-NOV-2019, the patient was vaccinated with 1st dose of a 3 dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, intramuscularly in the left arm , lot number 1621934, expiration date 29-JAN-2022 for prevention of human papillomavirus infection (HPV) related cancers (exact dose was not provided) in the physician's office. On the same date, as soon as she got vaccine she was very tired and patient was immediately tired. The patient sought medical attention in the doctor's office. No treatment was given to patient and she was only observed. It was also reported that the therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) would be continued.   The outcome of fatigue was reported as recovered on 11-NOV-2019. The causality assessment was not provided.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: GARDASIL 9 beginning at age 10 years old, and did not receive her second and third doses until she was 23 years old; The patient did not experience any symptoms.; This spontaneous report was received from a physician and refers to a 23-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, when the patient was 10 years old, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient did not receive her second and third dose until she was 23 years old. Physician noted that the second and third doses were spaced out by 3 months. The patient did not experience any symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender.  No information was provided regarding the patient´s (pt´s) concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location and lot # were not provided) by a pharmacist as recommended for the long-term prevention of shingles and zoster related conditions. Subsequently, on an unspecified date, the patient was treated in a local medical center for shingles.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The pt had not recovered from shingles.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age.  No information was provided regarding the patient´s (pt´s) concomitant medications, concurrent conditions or medical history.  In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location and lot # were not provided) by a health care provider as recommended for the long-term prevention of shingles and zoster related conditions.  Subsequently, on an unspecified date, the pt was treated by a health care provider for shingles.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The pt had not recovered from shingles.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus
Clinical narrative: Ramsey Hunt Syndrome; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age.  No information was provided regarding the patient´s (pt´s) concomitant medications, concurrent conditions or medical history. On or about 01-JUL-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location and lot # were not provided) by a pharmacist as recommended for the long-term prevention of shingles and zoster related conditions.  Subsequently, on an unspecified date, the pt was treated by a health care provider in a local medical center for shingles and Ramsey hunt syndrome.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The pt had not recovered from the events.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Ramsey hunt syndrome was considered to be a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This 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, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received on 09-DEC-2019, from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported. On or around 27-FEB-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a bad case of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt 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. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.  The event of shingles was considered to be disabling by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from the immunization coordinator concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 04-DEC-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX), lot # S020464, expiration date 02-JUL-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent MRK (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of (-2.1C) for 4 hours and 30 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Fatigue
Clinical narrative: The patient reported experiencing "fatigue" after receiving Pnemovax 23 vaccination; This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEMOVAX23) (strength, dose, schedule, lot# and expiry date was not reported) via route reported as injection for pneumonia vaccination. On an unknown date, the patient experienced fatigue after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEMOVAX23). The patient did not undergo any lab diagnostics or studies and did not seek medical attention. There was no associated product quality complaint. Outcome of the event was reported as not recovered. Causality assessment between the suspect therapy and reported event was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Hyperhidrosis, Influenza like illness, Malaise
Clinical narrative: fatigue; malaise; Low fever; Flu-like symptoms; Sweaty; Laying bed; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden. On an unknown date, the outcome of the fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden to be related to Shingrix.  Additional details were provided as follows: The healthcare professional (HCP) reported that a patient received her first dose of Shingrix and 8-12 hours later she was laying bed with fatigue, malaise, low fever, sweaty and flu-like symptoms that are still unresolved. The reporter was consented to follow up. The reporter stated that they can follow-up with the HCP. The HCP reported that she reported this information through VAERS previously.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fatigue; malaise; Low fever; Flu-like symptoms; Sweaty; Laying bed; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden. On an unknown date, the outcome of the fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, malaise, fever, influenza-like symptoms, sweating and bedridden to be related to Shingrix.  Additional details were provided as follows: The healthcare professional (HCP) reported that a patient received her first dose of Shingrix and 8-12 hours later she was laying bed with fatigue, malaise, low fever, sweaty and flu-like symptoms that are still unresolved. The reporter was consented to follow up. The reporter stated that they can follow-up with the HCP. The HCP reported that she reported this information through VAERS previously.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Sore arm; Chills; Extremely tired; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date after use of product, the patient experienced sore arm which she was unable to use or lift; chills; and was extremely tired. The outcome of events, sore arm which she was unable to use or lift, chills, and extremely tired, was unknown.  Information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Erythema, Lip swelling
Clinical narrative: Pt state she went to ER after shots because right arm was red and her upper lip became swollen she said the next day her bottom lip was swollen.  ER told her to take Benadryl and sent her home.  She said the ER DR thought it was from the MMR vaccine.  Pt stated no tongue swelling and no shortness of breath or other symptoms.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Eye pain, Fatigue, Headache, Nausea
Clinical narrative: The patient stated that he experiences weakness, headache, stinging eyes, achiness, nausea and tiredness beginning the morning after his second Shingrix vaccination.  The patient stated that he took aspirin and Tylenol to manage the symptoms. The symptoms resolved about a day and a half after onest.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The patient stated that he experiences weakness, headache, stinging eyes, achiness, nausea and tiredness beginning the morning after his second Shingrix vaccination.  The patient stated that he took aspirin and Tylenol to manage the symptoms. The symptoms resolved about a day and a half after onest.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: ARM SWELLED, TURNED VERY RED, HOT AND HARD FROM SHOULDER TO ELBOW LASTED ABOUT 2 FULL DAYS BEFORE IT STARTED TO RESOLVE
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave Fluzone High Dose instead of Regular Fluzone. No adverse event has of 12/10/2019 at 1615. Unsure if any reaction will happen. Later called 12/11/19 8:19 mother said they are not complaining of anything. Sent to school.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, PPV
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: This patient was due for four vaccines after his routine physical. I got the okay from Dr. to inform him of the 3 vaccines he additionally needed which were Influenza, HPV9, and Bexsero  (along with Hep A which was already discussed with Dr. prior). Patient agreed to get all four vaccines. I gave HPV9 and Hep A on his right deltoid intramuscularly.  I was supposed to give influenza and bexsero on his left deltoid. However, I accidentally gave pneumovax instead of Bexsero. Due to similar packaging, I overlooked the vaccine and prepped it as a Bexsero and also gave it intramuscularly.   I informed Dr. and my superiors of the incident that took place. Dr. advised to inform patient that this vaccine is not harmful although it is primarily given to elders or children with compromised immune systems. He states that it is okay for patient to return to office within 2-4 weeks to receive his Bexsero vaccination.  I was unable to reach patient despite attempting to reach him multiple times with number on file. I will make further attempts over the course of the week.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Client came in and stated that he had a red blistery rash covering most of his body except his face and neck. Worst were the blisters on the bottom of his feet. He had to be on 12 days of prednisone. The rash starting disappearing quickly after he started taking prednisone. However, they returned as soon as he stopped. Last lesions were 2 spots on his left arm around Thanksgiving. Client is free from rash and only has a few fading spots. He stated they were not painful or itchy.
Age: 28.0
Sex: F
Vaccine: JEV1, PPV, TDAP, TYP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Enlarging redness, heat and pain/swelling in Left UE since Monday. No underlying/active skin issues; has distant h/o molloscum in h.s. Reports 3" of redness and itch presented in LUE w/n several hours of the injection. Since then the area of redness has enlarged, itch resolved, now painful, enlarging, and firm/hot to the touch.  Rapid onset of redness and itch within hours of typhoid and pneumoccal vaccines given on 12/2/19; itching has since resolved and patient has developed a large, enlarging red indurated painful patch on L UE w/o any systemic sx or sign of anaphylaxis. Sx could represent an immediate type localized hypersensitivity reaction, a strong inflammatory rxn to one or both of the vaccines, and/or a secondary bacterial cellulitis. No purulence, fluctuance or known MRSA exposure. We discussed empiric coverage w/ abx that could cover MRSA and MSSA, individually and together. Will start tx to cover MSSA. Patient expresses agreement w/ above treatment plan, and all questions are answered to the patient's apparent satisfaction.   DICLOXACILLIN SODIUM 500 MG CAPS; 1 CAPSULE EVERY 6 HOURS; 5 DAYS; QTY 20 CAPSULE; 0 REFILLS (New) Rx Issued via Electronic (Network)
Age: 28.0
Sex: F
Vaccine: JEV1, PPV, TDAP, TYP
Symptoms: Skin warm
Clinical narrative: Enlarging redness, heat and pain/swelling in Left UE since Monday. No underlying/active skin issues; has distant h/o molloscum in h.s. Reports 3" of redness and itch presented in LUE w/n several hours of the injection. Since then the area of redness has enlarged, itch resolved, now painful, enlarging, and firm/hot to the touch.  Rapid onset of redness and itch within hours of typhoid and pneumoccal vaccines given on 12/2/19; itching has since resolved and patient has developed a large, enlarging red indurated painful patch on L UE w/o any systemic sx or sign of anaphylaxis. Sx could represent an immediate type localized hypersensitivity reaction, a strong inflammatory rxn to one or both of the vaccines, and/or a secondary bacterial cellulitis. No purulence, fluctuance or known MRSA exposure. We discussed empiric coverage w/ abx that could cover MRSA and MSSA, individually and together. Will start tx to cover MSSA. Patient expresses agreement w/ above treatment plan, and all questions are answered to the patient's apparent satisfaction.   DICLOXACILLIN SODIUM 500 MG CAPS; 1 CAPSULE EVERY 6 HOURS; 5 DAYS; QTY 20 CAPSULE; 0 REFILLS (New) Rx Issued via Electronic (Network)
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Injection site bruising, Injection site erythema, Pain
Clinical narrative: APPROXIMATELY 18 HRS AFTER INJECTION DEVELOPED A LARGE BASEBALL SIZE RED/BRUISED APPEARING AREA TO BACK OF LEFT ARM AT SITE OF MMRV INJECTION.  MOTHER INSTRUCTED TO USE MOIST COMPRESSES, TYLENOL/MOTRIN FOR PAIN/DISCOMFORT AND BENADRYL EVERY 6 HOURS X24-48 HOURS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave Fluzone High dose instead of Regular Fluzone. No adverse event noted has of 12/10/2019 1615p. 12/11/19 8:19 Called spoke with Mother-they are not C/O anything no redness, warmth or sever pain no C/O difficulty breathing.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling, Wrong product administered
Clinical narrative: 12/11/2019 The child was accidently given 0.25CC of Tuberculin PPD into the right lateral thigh instead of Influenza Vaccine on 12/07/19. The parents were informed as soon as the mistake was realized and were advised to monitor the child. I discussed with pediatric infectious disease (DR.) regarding the error. He stated that the child may not have any problems besides a small bump at the injection site. I rechecked the child on 12/09/19. The child had a small bump (Less that a pea size) in the right lateral thigh. Parents had more questions, so I referred to the pediatrics infectious disease group. Parents will make the appointment. Also, CDC was contacted and appropriate forms filled out.