chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: broke out in an itchy rash and large bumps around the injection site; broke out in an itchy rash and large bumps around the injection site; an itchy rash and large bumps around the injection site; This spontaneous report was received from the patient's mother referring to a 13 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On an unknown date the patient was vaccinated with first injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (syringe, dose, route, lot# and expiration date were not reported) for prophylaxis.    The patient broke out in an itchy rash and large bumps around the injection site about 30 hours after injection. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed. Device was not available for evaluation (Obtain reported as false). Outcome of all events was unknown.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all the events was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Hot feeling at the injection site; Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2020, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced after vaccination had redness at the injection site, soreness at the injection site, and a hot feeling at the injection site that were all still ongoing currently. The reporter consent to follow up. This case has been linked with case US2020167496 and US2020167494, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167496:Mother in law's case US-GLAXOSMITHKLINE-US2020167494:Husband's case
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Hot feeling at the injection; Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site erythema to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. In October 2019, the patient received flu vaccine in the left arm. The patient did not know the manufacturer of the flu vaccine she received. The patient reported redness at the injection site, soreness at the injection site, and a hot feeling at the injection site that began a couple hours after receiving the flu vaccine and resolved after a couple of days. The reporter consent to follow up. This case has been linked with case US2020167496 and US2020167494, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167496:Mother in law's case US-GLAXOSMITHKLINE-US2020167494:Husband's case
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breath holding, Crying, Emotional distress, Erythema, Eye movement disorder
Clinical narrative: Oral Rota given without incident. First injected was Pentacel to left thigh, patient did not cry. Second injected was Prevnar. Patient was noted to have very hard cry and then held her breath. MD notified and upon entry to the room, child was noted to have pallor with rolling eyes and head. Face appeared red and blochey. Patient then began crying and was difficult to console for approximately 2-3 minutes. MD then was able to calm patient down. Respirations remained non-labored, HR WNL, good tone, no erythema/edema to injection site. Right side of face and right lower extremity with some blochiness which improved as the patient relaxed. Patient ultimately fell asleep and was observed for around 10 minutes post vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pallor, Posture abnormal, Rash macular
Clinical narrative: Oral Rota given without incident. First injected was Pentacel to left thigh, patient did not cry. Second injected was Prevnar. Patient was noted to have very hard cry and then held her breath. MD notified and upon entry to the room, child was noted to have pallor with rolling eyes and head. Face appeared red and blochey. Patient then began crying and was difficult to console for approximately 2-3 minutes. MD then was able to calm patient down. Respirations remained non-labored, HR WNL, good tone, no erythema/edema to injection site. Right side of face and right lower extremity with some blochiness which improved as the patient relaxed. Patient ultimately fell asleep and was observed for around 10 minutes post vaccination.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Fatigue, Oropharyngeal pain
Clinical narrative: PATIENT EXPERIENCED SHIVERING/CHILLS AND SORE THROAT ABOUT 7 HOURS AFTER RECEIVING VACCINE.  PATIENT TOOK TYLENOL WHICH RELIEVED SYMPTOMS.  THE FOLLOWING MORNING, WHEN THE PATIENT REPORTED EFFECTS, HE WAS JUST FEELING FATIGUED/WEAK BUT NO OTHER ORIGINAL SYMPTOMS.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Intentional product use issue
Clinical narrative: No  Symptoms.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blister, Burning sensation, Rash erythematous
Clinical narrative: developed burning pain and then rash on abdomen 1-3 days after vaccine.  rash was erythematous patches with vesicles suggestive of shingles outbreak. visit over the phone on the holiday weekend ( 7/4) . patient did send photos via our secure patient communication portal.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Irritability, Mydriasis, Opisthotonus, Pallor, Respiration abnormal
Clinical narrative: Fussiness, Pupils dilated, arching back , funny breathing, turned pale.  This episode lasted for few seconds. History of Constipation and spitting frequently, therefore baby was on Hypoallergic formula Nutramigen.  Mom called EMS and baby was taken to ER where the baby was diagnosed at BRUE
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt describes: "the site was very tender, hot and painful with a big bump for 2-3 days after the injection.  It has been pretty much since the injection.  It is warm and no longer raised." as of conversation on 08/25/2020 with pt. Treatment: Cold compresses to the site of injection and observe for any changes.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; patient was administered an expired dose of PROQUAD; This spontaneous report was received from nurse and refers to a 5-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 30-JUL-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, injection, lot # S002925 and expiration date 28-JUL-2020 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse effects were reported.
Sex: U
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 patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 04-FEB-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the patient's inoculation with zoster vaccine live (ZOSTAVAX), on an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer 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 will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) as prescribed and/or administered by a healthcare provider at the physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a healthcare provider at the physician's office for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer 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 outcome of shingles was considered to be medically significant. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer 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 outcome of the event was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: TDAP
Symptoms: Encephalitis
Clinical narrative: Encephalitis; This case was reported by a consumer via interactive digital media and described the occurrence of encephalitis in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Shingrix (received on an unknown date), Pneumococcal vaccine (received on an unknown date) and Influenza vaccine (received on an unknown date).   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   The reporter considered the encephalitis to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, developed encephalitis from Tdap vaacine. The patient was not walked around barefoot near manure were nails, so not worried for it.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm to hurt & be sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain in arm. The reporter asked was it normal for arm to hurt and be sore.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: right arm started hurting severely; could not raise her arm.; she had a temp of 99.9; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included kidney transplant and crohn's disease. Concomitant products included infliximab (Remicade).   On 18th August 2020, the patient received the 1st dose of Shingrix. On 18th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased and fever. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and fever were unknown.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vacine in her right arm and later in the day her right arm started hurting severely, she could not raise her arm. She reported that through the night she had a temp of 99.9 and took tylenol and ice her injection site.  At the time of reporting the temperature was 98.4. The injection site was never swollen or red.  The reporter did not consent to follow up. MD followup call declined provided information from Shingrix FAQ regarding second shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: hot feeling at the injection site; soreness at injection site; redness at injection site; stiff neck; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site pain, injection site erythema and stiff neck. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site erythema and stiff neck were unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site erythema and stiff neck to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had redness at the injection site, soreness at the injection site, a hot feeling at the injection site, and a stiff neck after receiving the vaccination. The reporter did not consent to follow up. The reporter would not give any additional information about the adverse effects reported because did not feel comfortable doing so since it was not concerning herself. The reporter did not give permission to follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167494:same reporter US-GLAXOSMITHKLINE-US2020167493:same reporter US-GLAXOSMITHKLINE-US2020167490:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: vision changes in her left eye/ vision changes in the right eye; spider web in the field of vision; This case was reported by a other health professional via call center representative and described the occurrence of visual disturbance in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix. On 2nd March 2020, 1 days after receiving Shingrix, the patient experienced visual disturbance and eye floaters. On an unknown date, the outcome of the visual disturbance was not recovered/not resolved and the outcome of the eye floaters was unknown.   It was unknown if the reporter considered the visual disturbance and eye floaters to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and the patient had vision changes in her left eye on next day 2nd March 2020 where the patient saw a spider web in the field of vision.  These vision changed in the left eye were still ongoing at the time of reporting. It was reported that the patient recently developed vision changes in the right eye where the patient saw a spider web in her field of vision and this was still ongoing at the time of reporting. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: had developed chickenpox; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix. On 17th August 2020, 19 days after receiving Shingrix, the patient experienced chickenpox. On 19th August 2020, the outcome of the chickenpox was recovered/resolved.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient had developed chickenpox in the last few days (17th August 2020-19th August 2020) after getting the Shingrix vaccine. The patient did not consent to follow-up.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature decreased, Immediate post-injection reaction, Injection site erythema, Rash
Clinical narrative: Immediately after administration of vaccines, patient had redness around the L thigh and with rash on abdomen and around neck and face. No medications administered at all.  Pt observed and immediate vitals were temp of 98, HR 105, sat of 98% and BP of 84/52. 20 minutes later, temp 96.8, Sat 98% and HR 105. Rash completely disappeared.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Myalgia, Sluggishness
Clinical narrative: Sluggishness, headache, muscle ache,
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: In addition to the sore arm, tiredness, muscle pain, headache, shivering, stomach pain & nausea, I developed a rash on my chest, neck,abdomen, thighs, and inside of my arms.  The rash did not itch, but it was warm to the touch. [I did not have a fever]. It started in the afternoon of 8/23/20 and was pretty much gone by Tues, 8/25/20, late morning.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Rash, Skin warm
Clinical narrative: In addition to the sore arm, tiredness, muscle pain, headache, shivering, stomach pain & nausea, I developed a rash on my chest, neck,abdomen, thighs, and inside of my arms.  The rash did not itch, but it was warm to the touch. [I did not have a fever]. It started in the afternoon of 8/23/20 and was pretty much gone by Tues, 8/25/20, late morning.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling cold, Mobility decreased, Pyrexia, Throat tightness, Urticaria
Clinical narrative: Less than 24 hours after receiving vaccine pt. developed fever, chills and unable to get of bed for 3 days and hives and mother stated that pt. stated that "it felt like her throat was closing." Did not seek any medical treatment. Pt's mother stated that the feeling went away and mother was watching pt. the whole time. Allergic reaction was not reported within the week of administration. Mother stated that the symtoms went away and was wondering if pt should receive the other dose of the vaccine. This RN stated that pt should not receive the other dose if experiencing the previous symtoms as described.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Culture urine negative, Cyanosis, Febrile convulsion, Pyrexia, Respiratory arrest
Clinical narrative: HAD A SEIZURE EARLY AM OF SATURDAY, 8-22 -2020 HAD A FEVER ON 8-21-2020 OF AT LEAST 105 R  BABY TURNED BLUE & STOPPED BREATHING SO MOM STARTED CPR  CALLED 911 & TAKEN BY AMBULANCE TO ER DIAGNOSIS IN ER- FEBRILE SEIZURE, DISCHARGED AND FOLLOW UP IN OFFICE 8/24/2020.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Resuscitation, Seizure, Urine analysis normal
Clinical narrative: HAD A SEIZURE EARLY AM OF SATURDAY, 8-22 -2020 HAD A FEVER ON 8-21-2020 OF AT LEAST 105 R  BABY TURNED BLUE & STOPPED BREATHING SO MOM STARTED CPR  CALLED 911 & TAKEN BY AMBULANCE TO ER DIAGNOSIS IN ER- FEBRILE SEIZURE, DISCHARGED AND FOLLOW UP IN OFFICE 8/24/2020.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Musculoskeletal stiffness, Pain in extremity, Vision blurred
Clinical narrative: RASH, HEAT AT INJECTION SITE, PAIN AND STIFFNESS IN ARM.  BLURRED VISION STARTING ABOUT 24 HOURS AFTER INJECTION, INABILITY TO FOCUS  AND FIND FOCAL POINT. CONTINUED TO HAVE BLURRED VISION AND INABILITY FOCUSING.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Nausea, Syncope
Clinical narrative: fainting; weakness; nausea  after 2 days of injection.  one fainting, several spells of weakness for 2 more days.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dizziness, Dyspnoea
Clinical narrative: within 15-20 seconds after administering the vaccine, patient was feeling lightheadness and pain going down his back. Brief shortness of breath but resolved quickly thereafter. Had patient lay down on his back and checked for breathing for vitals, called 911 but refused any treatment. No need for an epipen either. Patient's pain resolved after 5-7 minutes and was able to stand up. Recommended he sit for a little bit longer, which he did and was able to go home. Patient was conscious and able to communicate with me throughout the timeframe.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTED REDNESS AT INJECTION SITE AND GROWING AS THE DAYS WENT ON. SHE SAID IT WAS SWOLLEN, TENDER TO TOUCH, BUT NOT ITCHY. SHE REPORTS TO NEVER HAVE HAD AN ISSUE WITH PREVIOUS INJECTIONS
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: extreme fatigue,  fever,  nausea,  headache
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Headache, nausea, sore arm.fatigue.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Swelling
Clinical narrative: Patient reported swelling and inflammation later that night and the next day causing her to go to her PCP where she received antibiotics.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Apporximately 6 hours after receiving vaccine developed non-painful, warm, red, rash on left arm.
Age: 55.0
Sex: F
Vaccine: FLU4, MMR, VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: vaccines given Friday (8/21/20) in the afternoon. pts arms were sore for a couple days. on sunday (8/23/20) pt developed diarrhea, nausea, and chills (w/o fever). Adverse event was reports Monday (8/24/20) afternoon.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: Patient called 8/24/2020 to report 24 hours of "severe"pain in left deltoid and inability to move her arm after this injection. Reported swelling of upper arm without redness or excessive warmth x 24 hours after injection. Spontaneous resolution of symptoms with exception of mild tenderness at injection site following first 24 hours after injection. Denies any other ill effects.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Documented hypersensitivity to administered product
Clinical narrative: No s/s patient was monitored in office for over an hour
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PEDVAX HIB was improperly stored and administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 28-JUL-2020, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number: S031500, expiration date 21-APR-2022 for prophylaxis (exact dose and route of administration were not provided). No adverse event was provided.  The vaccine experienced temperature excursion of 50 degrees of Fahrenheit for 1 hour and 46 minutes. Previous temperature excursion was not detected. The digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000307: US-009507513-2008USA000316:
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no additional AE/PQC reported.; The patient was given the Children/Adolescents (12 months through 18 years of age) dose rather than the Adults (19 years of age and older); patient is 19 years old.; This spontaneous report was received from a Licensed Practical Nurse referring to a currenly 19 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     In approximatly 2020 at 17 years old, the patient was vaccinated with their first dose of hepatitis a vaccine, inactivated(VAQTA) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.   Subsequently, on an unknown date in 2020, the patient was vaccinated with their second dose of hepatitis a vaccine, inactivated(VAQTA) 0.5 milliliter (strength, route,frequency, anatomical location,lot # and expiration date were unknown), the patient was given the Children/Adolescents (12 months through 18 years of age) dose rather than the Adults (19 years of age and older). No additional adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; the physician received a dose of M-M-R II via the intramuscular route in error; This spontaneous report was received from a male patient of unknown age, who also was a physician. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 06-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), 0.5 ml, lot # R036580, expiration date 17-DEC-2020, via the intramuscular route in error (instead of subcutaneous route) for prophylaxis.       No known adverse effects reported.
Sex: U
Vaccine: HEP, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: An unspecified number of patients were administered improperly stored  RECOMBIVAX HB and MMR II.; No Additional adverse events; This non-valid spontaneous report was received from a medical assistant, and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and previous drug allergies or reactions were not reported.    On an unspecified date, the patient's were vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (Lot number R030809; expiration date 24-OCT-2020) (dose, frequency and route were not provided) and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (thimerosal free) (Lot number R012001; expiration date 06-NOV-2020) (dose, frequency and route were not provided) for prophylaxis. The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).    The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) underwent a temperature excursion of below 2 (-15.2) degree Celsius (°C) for a period of 5 minutes; and later above 9 (14.9) °C for a period of 1 hour and 50 minutes. The vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) underwent a temperature excursion of above 9 (12.7) °C for a period of 5 minutes; and later above 9 (9.5) °C for a period of 1 hour and 45 minutes. The medical assistant reported that the patient did not experience any adverse event.  This report is non-valid due to lack of patients' identifiers.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Patient was administered an improperly stored PNEUMOVAX 23; No additional adverse events; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # S029542 with expiration date of 10-JUN-2021 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis.          combinationproductreport: Yes; brandname: PNEUMOVAX 23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Facial paralysis, Herpes zoster
Clinical narrative: Zoster related vision loss; Bell's Palsy; Zoster related vision loss; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On or about 30-SEP-3026, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions, at the pharmacy. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for Bell's Palsy (facial paralysis) and for zoster related vision loss (herpes zoster and blindness). As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient have and will continue suffering ongoing injuries, including but not limited to significant medical and related expenses as result of these injuries, losses and costs included care for hospitalization, physical 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. At the time of the report, the patient had not recovered from the events. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of facial paralysis and blindness were considered medically significant.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report was received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 18-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml once, lot # S008695, expiration date not reported, but upon internal validation established as 21-MAR-2021, strength and route were not reported) which was underwent the temperature excursion for prophylaxis (product storage error). The storage temperatures of varicella virus vaccine live (Oka/Merck) (VARIVAX) were -9.2 Celsius degrees for 30 minutes and -14 Celsius degrees to -10 Celsius degrees (-14.3 Celsius degrees) for 30 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse event (AE) or product quality complaint (PQC).   This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011114: US-009507513-2008USA011596: US-009507513-2008USA011215: US-009507513-2008USA011552:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE/PQC reported.; patient received expired VAQTA; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 17-AUG-2020, the patient was vaccinated with a expired hepatitis a vaccine, inactivated (VAQTA) (lot # S018772, expiration date not reported, but upon internal validation established as 07-JUL-2020, 1 injection, intramuscular) for prophylaxis (expired product administered). The nurse questioned whether the patient need to be re-vaccinated or not. No further adverse event (AE)/ product quality complaint (PQC) reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S018772; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: FLUN3
Symptoms: Drug ineffective, Malaise
Clinical narrative: I GOT IT ONCE YEARS AGO AND I GOT SO SICK; THEY FOUND IT DIDN'T WORK; A spontaneous report has been received from a consumer. The report concerns a female patient  of Unknown ethnic origin.    No medical history was reported.    No concomitant products were reported.    The patient started treatment with Flumist (influenza virus vaccine live, intranasal), nasal, on an unknown date.     The report described lack of effect for Flumist. The reported term was they found it didn't work (Preferred term: Drug ineffective).     On an unknown date, the patient experienced i got it once years ago and i got so sick (preferred term: Malaise).     The outcome of the event(s) of i got it once years ago and i got so sick and they found it didn't work was unknown.     The events  i got it once years ago and i got so sick and they found it didn't work were considered non-serious.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Erythema, Feeling abnormal, Injection site erythema
Clinical narrative: pain in neck; body aches; nausea; chills; drugged feeling; fever; redness around injection site; pain in hands; itching in hands; redness in hands; burning in hands; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy. Concomitant products included montelukast sodium (Singulair), famotidine (Pepcid Ac) and fexofenadine hydrochloride (Allegra).   On 13th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, 1 days after receiving Shingrix, the patient experienced neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the neck pain, general body pain, nausea, chills and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm.  The patient reported that on next day, had chills, nausea, body aches, pain in neck, and a drugged feeling that lasted until Sunday. The patient also experienced fever that resolved on 15th August 2020. The patient received Benadryl (NOS). The patient also developed redness around the injection site, burning in hands, redness in hands, itching in hands, and pain in hands and these are all still ongoing currently.  The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: pain in neck; body aches; nausea; chills; drugged feeling; fever; redness around injection site; pain in hands; itching in hands; redness in hands; burning in hands; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy. Concomitant products included montelukast sodium (Singulair), famotidine (Pepcid Ac) and fexofenadine hydrochloride (Allegra).   On 13th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, 1 days after receiving Shingrix, the patient experienced neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the neck pain, general body pain, nausea, chills and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm.  The patient reported that on next day, had chills, nausea, body aches, pain in neck, and a drugged feeling that lasted until Sunday. The patient also experienced fever that resolved on 15th August 2020. The patient received Benadryl (NOS). The patient also developed redness around the injection site, burning in hands, redness in hands, itching in hands, and pain in hands and these are all still ongoing currently.  The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pain in neck; body aches; nausea; chills; drugged feeling; fever; redness around injection site; pain in hands; itching in hands; redness in hands; burning in hands; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy. Concomitant products included montelukast sodium (Singulair), famotidine (Pepcid Ac) and fexofenadine hydrochloride (Allegra).   On 13th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, 1 days after receiving Shingrix, the patient experienced neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the neck pain, general body pain, nausea, chills and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, general body pain, nausea, chills, feeling abnormal, fever, injection site erythema, pain in hand, itching both hands, red hands and extremities burning sensation of to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm.  The patient reported that on next day, had chills, nausea, body aches, pain in neck, and a drugged feeling that lasted until Sunday. The patient also experienced fever that resolved on 15th August 2020. The patient received Benadryl (NOS). The patient also developed redness around the injection site, burning in hands, redness in hands, itching in hands, and pain in hands and these are all still ongoing currently.  The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Neurological symptom, Pyrexia
Clinical narrative: Caller says she did not have an anaphylaxis reaction, but had a "temp 103F, cellulitis in whole upper arm and neurological symptoms".; Caller says she did not have an anaphylaxis reaction, but had a "temp 103F, cellulitis in whole upper arm and neurological symptoms".; Caller says she did not have an anaphylaxis reaction, but had a "temp 103F, cellulitis in whole upper arm and neurological symptoms".; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient medical history was not reported. Patient was allergic to tetanus. The patient's concomitant medications were not reported. Patient read it (pneumococcal 13-val conj vac (dipht crm197 protein)) was contraindicated for patient allergic to didiphtheria toxoid-containing vaccine. She was not sure which component of vaccine she is allergic to. She did not have an anaphylaxis reaction, but had a "temp 103F (Fahrenheit), cellulitis in whole upper arm and neurological symptoms". Patient was supposed to get the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine at the reporting date but did not. Outcome of events was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: The association between the event cellulitis in whole upper arm with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on the limited information and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.