chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Insomnia, Migraine, Rash
Clinical narrative: Head to toe rash all over body, baseball sized red and swollen at injection site, migraines and blurry vision, trouble sleeping
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Vision blurred
Clinical narrative: Head to toe rash all over body, baseball sized red and swollen at injection site, migraines and blurry vision, trouble sleeping
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pallor, Paraesthesia oral
Clinical narrative: Staff member came to clinic and received her flu vaccine, left the clinic with no reports immediate reactions. went back to work place. A bit later a coworker came to clinic to inform us she had a reaction and was in the ED. Coworker stated she was pale, the red cheeks, and her tongue was starting to feel funny and they brought her to ED.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dysphagia, Paraesthesia oral
Clinical narrative: Staff member came to clinic and received her flu vaccine, left the clinic with no reports immediate reactions. went back to work place. A bit later a coworker came to clinic to inform us she had a reaction and was in the ED. Coworker stated she was pale, the red cheeks, and her tongue was starting to feel funny and they brought her to ED.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash macular
Clinical narrative: Client states ,via phone call ,that 2 days after vaccine administration 9/28., she experienced blotchy redness on cheek area of her face. No itching or shortness of breath. As of 9/30 redness has faded.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: Sore and very painful and swollen and red at injection site. Headache, aches
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: SEVERE FEVER
Age: 28.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Rash
Clinical narrative: LOCALIZED RASH ALONG THE MIDDLE OF THE BACK AND SHOULDERS.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient woke up with a Red rash around her neck, itching.  Patient had redness at injection site also
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Patient received her flu vaccine on 9/30/2019.   Woke this morning with a red bumpy rash , itching on her Lt upper Thigh.  Patient reports no changes in her health, denies any food allergies or changes in any home products.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: hives on neck and chest patient reports taking Benadryl and using hydrocortisone cream on the rash area with improvement denies SOB / trouble swallowing/ any other symtpoms refused appointment in office for this, she simply called in to alert us of her reaction. she told me over the phone she tested positive for allergic reaction to eggs in the past but never had a problem with the flu shot in the past.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; patient was inadvertently administered one dose of expired VAQTA (lot R018935 exp 09/05/2019) on 09/06/2019; This spontaneous report was received from a nurse and refers to a 12-month-old female patient. No information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was reported. On 06-SEP-2019, the patient was inadvertently vaccinated with one dose of expired hepatitis a vaccine, inactivated (VAQTA) lot # R018935, expiration date: 05-SEP-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: two unspecified patients, who were over the age of 64 years old and already had cervical cancer; two unspecified patients, who were over the age of 64 years old and already had cervical cancer; No adverse events; This spontaneous report was received from a pharmacist via a company representative and refers to a female patient over the age of 64 years old. The patient had already experienced cervical cancer.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were reported.   This is one of two reports received from the same reporter (linked with MARRS # 1910USA000552).; Sender's Comments:  US-009507513-1910USA000552:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Laryngospasm
Clinical narrative: after first dose, patient experienced laryngospasms while in the office; This spontaneous report was received from a nurse practitioner via a company representative regarding a 2-month-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were unknown by the reporter, however it was reported that there might have been other vaccinations (non oral) on an unspecified date (reported as "that day").  On an unspecified date (also reported as "about 1.5 to 2 years ago"), the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for rotavirus (lot number, expiration date, dose and frequency were not reported).  While in the office for the 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), after being administered with the first dose, the infant experienced laryngospasms. No treatment was given for this adverse event (AE). No laboratory diagnostics or studies were performed regarding the event. The patient sought medical attention. Limited information was provided by the reporter. The patient recovered from the event in 15 to 20 minutes.   The relatedness between the event of laryngospasms and the suspect vaccination was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injection site necrosis
Clinical narrative: Deltoid went necrotic after getting the dose at the site; This spontaneous report was received from a nurse prescriber regarding a 15 year old female patient. Patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the deltoid (dose, strength, lot/batch and expiry: unknown) for prophylaxis. It was reported that, on an unknown date, deltoid went necrotic after getting the dose at the site (injection site necrosis). Treatment was received for the event. Patient sought medical attention. There was no adverse effect with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Cancer was not involved. The outcome of injection site necrosis was recovering. Causality of the event with respect to suspect therapy was unknown.  Upon internal review, the event injection site necrosis was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: two unspecified patients, who were over the age of 64 years old and already had cervical cancer; two unspecified patients, who were over the age of 64 years old and already had cervical cancer; No adverse events; This spontaneous report was received from a pharmacist via a company representative and refers to a female patient over the age of 64 years old. The patient had already experienced cervical cancer.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were reported.   This is one of two reports received from the same reporter (linked with MARRS # 1909USA004120).; Sender's Comments:  US-009507513-1909USA004120:
Sex: U
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: passed out; This case was reported by a nurse via sales rep and described the occurrence of passed out in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Menveo.  Additional information was reported as follows: This case was reported by the registered nurse. The age at vaccination was not reported. After vaccination, the patient had passed out. The reporter wanted know if that was normal. This case is 1 of 4 cases reported by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Adverse drug reaction
Clinical narrative: I had some of the side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, 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 Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the patient got the Tdap vaccine so she could be around her new grandson who is expected in February.  The patient had some of the side effects after receiving Tdap Vaccine but it was still worth it. The case has been linked with the case US2019AMR174475, reported by same reporter.
Sex: M
Vaccine: TDAP
Symptoms: Adverse drug reaction
Clinical narrative: Had some of the side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, 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 Tdap Vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. It was reported that the patient got the shot and also had some of the side effects. The case has been linked with the case US2019AMR174465, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Myalgias; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (in November 2015, received Zostavax).   On 1st April 2019, the patient received the 1st dose of Shingrix. On 1st April 2019, less than a day after receiving Shingrix, the patient experienced fever, chills and myalgia. On an unknown date, the outcome of the fever, chills and myalgia were recovered/resolved.   It was unknown if the reporter considered the fever, chills and myalgia to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The medical assistant reported that, after vaccination with dose of Shingrix, the patient had very unpleasant side effects with fever, chills, myalgias for 36 hours. The reporter did not consent to follow up.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Pruritus genital
Clinical narrative: itching; itching spread all over her body/ take out her hearing aid to scratch the area; quick pin stick in her arm and then the itching starts; This case was reported by a consumer via call center representative and described the occurrence of genital itching in a 87-year-old male patient who received Herpes zoster (Shingrix) (batch number J4D5J, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th May 2018 (batch number B9739, expiry date unknown)). Concomitant products included cardiovascular system drugs (Heart Medication).   On 25th September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced genital itching, generalized pruritus and tingling skin. The patient was treated with dermatologicals nos (Lotion). On an unknown date, the outcome of the genital itching, generalized pruritus and tingling skin were not recovered/not resolved.   It was unknown if the reporter considered the genital itching, generalized pruritus and tingling skin to be related to Shingrix.  Additional details were provided as follows: The patient did not experience any reactions until 3 months before the reporting date and then her genital area started to itch.   Within 3 to 4 days later, the itching spread all over her body, she specifically mentioned her head, arms, back and ears.   She said it felt like a quick pin stick in her arm and then the itching started. The itching come and go but was not resolved. The patient's physician took her off all her medications including her heart medication but that did not help with the itching. Her dermatologist prescribed various lotions and none relieved the itch. There was no rash or pimples of any kind. The patient was suffering with the symptom in her ear when she was reporting these adverse events.  She had to take out her hearing aid to scratch the area while speaking to the call center representative. The patient consented to follow up and also provided her physician's details.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Rash vesicular
Clinical narrative: Inappropriate age at vaccine administration; Shingles rash; Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2S7, expiry date 15th November 2021) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced shingles and vesicular rash. On 16th September 2019, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles, vesicular rash and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The pharmacist reported that patient received first dose of Shingrix and had now been diagnosed with shingles rash.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (R) arm swelling, erythema and pain 24-48 hrs after injection - area involved 4 x 6"
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Her arm started to swell that night and she developed hives.  By the next morning the swelling was about half the size of a grapefruit and very red.  It was also itchy. Patient took Advil for two days.  Her arm is almost back to normal.  She states the redness is fading and her arm is almost flat. The hives have disappeared. Her arm is still a little itchy.  Provider encouraged pt to take Benadryl.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Angioedema, Lip swelling, Rash
Clinical narrative: Patient presented 1 hour post vaccination with Rash - puff lips...Treated 25mg diphenhydramine every 2 hours x 24 hour next developed angioedema and needed to present to ED.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Neck pain
Clinical narrative: Left neck/shoulder stiffness and pain
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site nodule, Pyrexia
Clinical narrative: The family states the injections were given without incidence. She had mild fever for 2 days. There was erythema at the injection sites, about the size of a nickel. MOP was concerned the left thigh site is too lateral. She continues to have hard lumps at both injection sites. She does not seem to have pain and they do not impari activity. She is otherwise baseline. She tolerated her 2 month vaccines without incidence. Physical exam showed  palpable bilateral firm, mobile, irregular, knotty, pea-sized, nontender, left slightly larger than right nodules at quadriceps injection sites with superficial skin discoloration but no signs of other local site inflammation. Family reported nodules still present on 14 AUG 2019. F/u was planned for SEPT. We telephoned on -1 OCT since they hadn't scheduled and report was sites improved and visit  was declined by family.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, minus the fever.  Body aches, extreme fatigue, headache
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site reaction, Pyrexia, Rash macular
Clinical narrative: Chills then fever which were gone by morning.  I had blotchy red marks around the site, but no itching.  Redness was gone by Sunday night.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Patient felt weak and light headed and had a syncope episode in the chair 5-10 minutes after injection was given
Age: 66.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient came in 7 days post immunization to report  that she felt feverish, lethargic, and reported at first she was only had nausea to then stating she did vomit one time and by the end of taking her report had said she actually vomited 3 times.  All symptoms lasted for one day per patient.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: RED RAISED AREA 2 INCHES IN DIAMETER NO ITCHING SHE STATES FEELS WARM
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Erythema, Lacrimation increased, Sensation of foreign body
Clinical narrative: Five minutes after injection child was leaving and started coughing, felt like she couldn't breathe, face turned red, and eyes began to water.  Coughing subsided, but child reported that it felt like something was in throat.  Face was still red and eyes tearing.  Vital signs obtained BP 114/72. HR 86, SpO2 97%.  Lung sounds clear bilaterally and no wheezing heard on auscultation.  Reaction seemed to subside and child was no longer coughing or reporting feeling like something was in throat.  Redness in face resolved with tearing.  15 minutes post injection redness noted at injection site in oval shape extending approximately 3 inches.  20 minutes post injection MD to see patient.  Child showing no more signs of reaction.  All symptoms resolved.  No redness at injection site 25 min post injection.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches, headache, diarrhea, fever of 100.5, nausea
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Confusional state, Dizziness, Dyspnoea
Clinical narrative: My arm that got the injection was hurting too bad to lift up to shoulder height. This started two hours after the injection. Then shortly after the arm pain, it felt like there was a weight on my chest, which caused difficulty breathing. At that same time, I started feeling dizzy and confused.  About 5 hours after injection, I was shivering and cold feeling, but my skin was hot to the touch.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Injection site pain, Pain in extremity, Skin warm
Clinical narrative: My arm that got the injection was hurting too bad to lift up to shoulder height. This started two hours after the injection. Then shortly after the arm pain, it felt like there was a weight on my chest, which caused difficulty breathing. At that same time, I started feeling dizzy and confused.  About 5 hours after injection, I was shivering and cold feeling, but my skin was hot to the touch.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Headache, Malaise, Pyrexia
Clinical narrative: fever 100.1, headache and dizziness-overall sick and yucky feeling
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Localized left arm erythema
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash over midsection, red not raised
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain to site of injection
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Joint swelling
Clinical narrative: Extensive limp swelling to knee.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: very sore and swollen UPPER LT. ARM very PINK AND WARM UPPER FOR 8 days 2 FIFTY CENT SIZED bletches oN my chEST no itcHING, chesT site
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Myalgia, Somnolence, Urinary tract disorder
Clinical narrative: I was weak during the dates listed, dizzy also very sore in the muscles. also was having faint like my blood sugar might have been low or sugar level low also drownsy. I will not take this Flu shot again  Did get a urinary track during week of symptoms of vaccine I do not know if From the Vaccine.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient reported redness & swelling, pain in injection site. Warm to touch patient advised to apply ice, take NSAID & diphenhydramine & to contact PCP if worsens.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse events; A patient received a dose of PEDV AX on 02/01/2019, on 04/01/2019, on 06/01/2019, and on 09/09/2019; This spontaneous report as received from an administrator refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 01-FEB-2019, the patient was vaccinated with a first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot#, expiration date, dose and route of administration were not provided) for prophylaxis. The patient was vaccinated with a second, third and fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot#, expiration date, dose and route of administration were not provided) for prophylaxis, on 01-APR-2019, 01-JUN-2019 and 09-SEP-2019, respectively. No known adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  In or around October 2016, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using it. 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 the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). The reporter considered the event to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  In or around July 2016, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using it. 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 the pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). The reporter considered the event to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired; This case was reported by a consumer and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received Shingrix. On 25th September 2019, 1 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient reported that the patient received a Shingrix vaccination yesterday and feeling tired at the time of reporting. The asked if this was normal.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Herpes zoster, Pruritus, Swelling, Vaccination failure
Clinical narrative: vaccination failure; Shingles; swelling in groin area; difficulty walking; itching; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and 183 days after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, groin swelling, walking difficulty and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, groin swelling, walking difficulty and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix. It was unknown if the reporter considered the groin swelling and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed a widespread case of shingles. The shingles was itchy and the patient developed swelling in the groin area had difficulty walking as a result. The reporter consented for follow up.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site scab, Injection site swelling, Injection site vesicles
Clinical narrative: patient experience fluid-filled blister at injection site in the evening after receiving immunization, immunization site was red and swollen; blister popped during the night.    Patient inquired about it and showed pharmacist the area on Tuesday.  Area was no longer red or raised, a scabbed area approximately 1/8' was visible
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Immunisation, Underdose, Wrong technique in product usage process
Clinical narrative: Patient stated that some of the vaccine dripped out on her arm, she was worried that she did not get the full shot.   She came back a few days later and I gave her another 0.2 ml of a flu shot.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt. had a syncopal episode immediately following third vaccine. Pt. was assisted to lay down on exam table. Pt. regained consciousness within 3-4 seconds. Pt. was given juice and crackers and continued lying down for 10 minutes after episode. Pt. was assessed by physician. Pt. felt well enough to leave the office.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood test, Computerised tomogram, Dysstasia, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: About 8pm on the 27th of sept,,  as I was about to get up from a sitting position , I encountered such severe vertigo that I could not stand up. I waited a bout 15 minutes to see if it would subside but it only got worse and was accompanied by severe nausea. My husband then checked the paperwork I received after my flu shot at 12:pm that day and per instructions carries me to our auto and drove me to the ER. The instruction sheet stated this was a serious side affect.                                               I encountered such severe
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Nausea, Vertigo
Clinical narrative: About 8pm on the 27th of sept,,  as I was about to get up from a sitting position , I encountered such severe vertigo that I could not stand up. I waited a bout 15 minutes to see if it would subside but it only got worse and was accompanied by severe nausea. My husband then checked the paperwork I received after my flu shot at 12:pm that day and per instructions carries me to our auto and drove me to the ER. The instruction sheet stated this was a serious side affect.                                               I encountered such severe
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Ataxia, Erythema, Headache, Incontinence, Muscular weakness
Clinical narrative: Beginning the night after the immunizations, she began to experience headache, neck soreness, swollen and red upper arms, severe nausea, muscle weakness/ataxia, and incontinence. These were severe from Friday night to Sunday night. Beginning Monday morning they began to decrease in severity.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Nausea, Neck pain, Peripheral swelling
Clinical narrative: Beginning the night after the immunizations, she began to experience headache, neck soreness, swollen and red upper arms, severe nausea, muscle weakness/ataxia, and incontinence. These were severe from Friday night to Sunday night. Beginning Monday morning they began to decrease in severity.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: patient presented to office with redness at injection site
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient has been experiencing ongoing muscle pain since flu shot was administered. She called 10/1/19 approximately 1 month after getting flu shot noting she is still experiencing pain and soreness in her arm. She indicates she is a nurse and has had many flu shots before and hasn't experienced this previously. She notes she felt as though immunization administration technique was correct.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has been experiencing ongoing muscle pain since flu shot was administered. She called 10/1/19 approximately 1 month after getting flu shot noting she is still experiencing pain and soreness in her arm. She indicates she is a nurse and has had many flu shots before and hasn't experienced this previously. She notes she felt as though immunization administration technique was correct.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Upper arm pain for almost a month now
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Upper arm pain for almost a month now
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Decreased appetite, Dyspnoea, Ear pain, Fatigue
Clinical narrative: High fevers of over 101.5; severe body ache/malaise; shortness of breath; elevated blood pressure; extreme fatigue; no appetite-- all these symptoms continued over the course of 2 weeks, followed by severe, sporadic internal pain in the left ear--- my physician believed this was post-herpetic trigeminal nerve pain. Lab tests performed at clinic indicated raised white blood count but no evidence of bacterial infection. Treatment discussed for me was a visit to the neurologist, an MRI and putting me on a course of anti-seizure med's, long term, to control the nerve pain. Fortunately, after two days of extreme pain, my symptoms went away.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Malaise, Pain, Pyrexia, Trigeminal neuralgia
Clinical narrative: High fevers of over 101.5; severe body ache/malaise; shortness of breath; elevated blood pressure; extreme fatigue; no appetite-- all these symptoms continued over the course of 2 weeks, followed by severe, sporadic internal pain in the left ear--- my physician believed this was post-herpetic trigeminal nerve pain. Lab tests performed at clinic indicated raised white blood count but no evidence of bacterial infection. Treatment discussed for me was a visit to the neurologist, an MRI and putting me on a course of anti-seizure med's, long term, to control the nerve pain. Fortunately, after two days of extreme pain, my symptoms went away.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: High fevers of over 101.5; severe body ache/malaise; shortness of breath; elevated blood pressure; extreme fatigue; no appetite-- all these symptoms continued over the course of 2 weeks, followed by severe, sporadic internal pain in the left ear--- my physician believed this was post-herpetic trigeminal nerve pain. Lab tests performed at clinic indicated raised white blood count but no evidence of bacterial infection. Treatment discussed for me was a visit to the neurologist, an MRI and putting me on a course of anti-seizure med's, long term, to control the nerve pain. Fortunately, after two days of extreme pain, my symptoms went away.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 7X 8 cm area of redness approximately 2 inches below site of injection.  Area is also swollen and has some fluid collection at the lower portion of the redness.  Client reports itching in the am, but has decreased.  Voices discomfort to touch similar to what a bruise feels like. Discomfort level is 2/ 10 when touched.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Drug withdrawal syndrome, Feeling abnormal
Clinical narrative: Pt came back from receiving flu shot, states feels funny. When asked states throat feels "weird", feels dizzy, and unsteady on feet. Pt also c/o withdrawal symptoms from narcotics. VSS, pulse and heart rate regular. Spoke to provider, gave 25 mg of PO benadryl. Pt remained stable and observed for 30 minutes and improved. Ambulated independently out of office. Provider aware
Age: 50.0
Sex: F
Vaccine: FLU4, PPV, VARZOS, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: STARTED 9/29/19 NIGHT AROUND MIDNIGHT, WITH HEADACHE & NAUSEA. THEN BODY ACHES & CHILLS, EVERYTHING HURT. WORST AT LATER PART OF DAY ON 9/30/19.  DR VISIT ON 10/1 @ 12:15PM, DR SAID REACTION TO VACCINE, DR SAID SHE'S SEEN THIS REACTION BEFORE. 10/1 STILL CHILLS COME & GO, & SWEAT, AND HEADACHE, NAUSEA & ACHES CONSTANT
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Fever 103.1 a little later it went down to 101.3, left side numbness from head to foot, chest/back pain, headache, chills, fatigue, loss of appetite, soreness
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Fever 103.1 a little later it went down to 101.3, left side numbness from head to foot, chest/back pain, headache, chills, fatigue, loss of appetite, soreness
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Nerve injury, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient has had numbness, tingling, and pain in his arm, shooting down to his hand since his shot.  He is going to see a neurologist soon but his doctor thinks we hit a nerve.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Malaise
Clinical narrative: COMPLETE LEFT ARM NUMBNESS AS WELL AS SORENESS AT SITE.  TEMPERATURE, OVERALL MALAISE 24 HR
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Swelling of left bicep, streaks of red down bicep from injection site to elbow, skin hot & painful to the touch. 48 hours after injection, severe nausea, weakness and muscle pain. Nausea subsided after another 24 hours; weakness and muscle pain persist.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: Swelling of left bicep, streaks of red down bicep from injection site to elbow, skin hot & painful to the touch. 48 hours after injection, severe nausea, weakness and muscle pain. Nausea subsided after another 24 hours; weakness and muscle pain persist.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: A 37 year-old  M received HEP A IM at 8:55 a.m. Patient was monitored for 15-minutes without any complaints of weakness, dizziness, or allergic response.  10:39 a.m. Received call too Clinic from mission reporting that patient was feeling dizzy. Upon arrival, patient was found sitting in a chair awake, alert, and oriented complaining of feeling dizzy.  Patient denies blurry vision, chest pain or shortness of breath.  BP 150/88; HR 88  Bilateral breath sounds clear to auscultation; heart sounds with regular rate and rhythm, no murmurs.  Assessment: Dizziness   Plan: Monitor patient for s/s of respiratory or cardiac distress Call fire rescue 9-1-1 Remain with patient until rescue arrived  Note; Upon fire rescue arrival, patient requested transport to nearest hospital for further evaluation.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. reported redness and swelling at site and down to inside of arm starting on day 3 after inj. It worsened from day 3 to day 5 with warmth to touch and then started to resolve. She reports complete resolution at this time. No treatment was required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Retinal injury
Clinical narrative: Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles and retinal damage.; Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered shingles and retinal damage.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around May 2012, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles (herpes zoster) and retinal damage (retinal injury). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using it. 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, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, retinal injury was determined to be a medically significant event.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of PEDVAX was administered to the patient; No adverse effects.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # N024570 and expiration date: 01-MAY-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. No adverse effects were reported.  The vaccine was stored in the temperature below 36 Fahrenheit (F) in 32.1 F for 8 hours. There was no previous temperature excursion. The improper storage was recorded because of digital "data logger".
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Migraine, Pain
Clinical narrative: migraine; felt awful; Pain; severe flu / flu-like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of pain in a 55-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, less than 2 years after receiving Shingrix, the patient experienced pain, influenza-like symptoms, migraine and feels awful. On an unknown date, the outcome of the pain, influenza-like symptoms and feels awful were recovered/resolved and the outcome of the migraine was unknown.   It was unknown if the reporter considered the pain, influenza-like symptoms, migraine and feels awful to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported pain and severe flu-like symptoms following receipt of Shingrix dose 1 that lasted about 1 day.  The patient stated a migraine was triggered and she felt awful for about a day, then was fine.  The patient did not experience this severe type of reaction with dose 2. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Insomnia, Myalgia, Pyrexia
Clinical narrative: myalgias; slight fever; difficult to sleep; sweating profusely; injection site pain; This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On 19th September 2019, the patient experienced myalgia, fever, difficulty sleeping and excess sweating. The patient was treated with paracetamol (Acetaminophen). On 21st September 2019, the outcome of the myalgia was recovered/resolved. On an unknown date, the outcome of the fever, difficulty sleeping and excess sweating were unknown and the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the myalgia, fever, difficulty sleeping, excess sweating and injection site pain to be related to Shingrix.  Additional details were provided as follows: This report concerns to patient himself. The patient did not receive any other vaccine at the same time. Approximately 8 hours after receiving a dose of Shingrix, the patient began experiencing myalgias and slight fever (101 degrees F). The patient took acetaminophen which helped, and during the evening, it was difficult to sleep for him and he was sweating profusely. The myalgias continued into 20th September 2019 during which the patient continued taking acetaminophen. The patient also experienced some injection site pain which was continuing at the time of reporting.  The myalgias fully resolved by A.M. of 21st September 2019 and the patient had ceased acetaminophen. The patient stated, the injection site pain was minor. There were no other local reactions. The suspect vaccines course was not discontinued. The report did not include any product complaint. The reporter agreed to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Weakness; fatigue; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, weakness, fatigue and muscle pain. On an unknown date, the outcome of the fever, weakness, fatigue and muscle pain were unknown.   It was unknown if the reporter considered the fever, weakness, fatigue and muscle pain to be related to Shingrix.  Additional case details were provided as follows: The patient reported for himself. The age at vaccination was not reported. The patient experienced fever, weakness, fatigue and muscle aches after receiving Shingrix vaccine. The patient would not provide any additional details.