chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pain
Clinical narrative: Lump at injection site; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. On 12th April 2019, less than a day after receiving Shingrix, the patient experienced injection site lump and pain. On an unknown date, the outcome of the injection site lump and pain were unknown.   It was unknown if the reporter considered the injection site lump and pain to be related to Shingrix.  Additional details were provided as follows: The patient had a lump approximately golf ball size formed at the injection site.   No additional details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Varicella infection; This case was reported by a pharmacist via call center representative and described the occurrence of varicella in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced varicella. On an unknown date, the outcome of the varicella was unknown.   It was unknown if the reporter considered the varicella to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The pharmacist reported that the patient developed chickenpox after receiving the 1st dose of Shingrix.  The health care professional declined to provide any further information at the time of reporting.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: Therapy non-responder; Circumstance or information capable of leading to medication error; Drug dose administration interval too short; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B and not applicable after receiving Engerix B, the patient experienced therapy non-responder, circumstance or information capable of leading to medication error and drug dose administration interval too short. On an unknown date, the outcome of the therapy non-responder, circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient was having a negative titer reading after receiving childhood vaccination and hence wanted to complete a second series of Engerix-B. The patient was planning on taking the second dose of the series prior to the 1 month established on the local label due to school requirements and if administered would lead to circumstance or information capable of leading to medication error and shortening of vaccination schedule.      Lab Comments: On an unknown date, the patient's Hepatitis B surface antibody was negative
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid irritation, Eyelid rash, Injection site reaction, Oral mucosal eruption
Clinical narrative: eyelid irritation; rash on mouth; Eyelid rash; injection site reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received Shingrix (intramuscular). On 28th March 2019, immediately after receiving Shingrix, the patient experienced injection site reaction. On 1st April 2019, the patient experienced eyelid irritation, rash mouth and eyelid rash. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the eyelid irritation, rash mouth and eyelid rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix. The reporter considered the eyelid irritation, rash mouth and eyelid rash to be unrelated to Shingrix.  Additional details were provided as follows: The patient experienced an injection site reaction right away after the vaccination, that resolved within a couple days. The patient developed a hot rash on her eyelids and side of her mouth. The patients doctor prescribed her prednisone and Zyrtec, and while taking prednisone the rash went away. The patient finished her course of prednisone and the rash has returned. The patients doctor did not think the rash was related to Shingrix. The reporter gave consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Injection site pain; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2018, the patient received the 1st dose of Shingrix .5 ml. On 4th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, fever and chills. On 5th September 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and chills to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on right arm. The patient experienced fever and chills the evening of vaccination that lasted 24 hours.  The patient also had injection site pain that lasted a few days.  The reporter did not give consent to follow up. For tolerance after 2nd dose refer case US2019GSK074800.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: temperature excursion for Adacel/Temp: 48.2; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 4 Adult female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was exposed to temperature (Temp: 48.2) for 8 hours.   The reported temperature excursion for Adacel/Temp: 48.2 occurred at unknown gestation period<<the gestation period at onset and gestation period at exposure data needs to be populated, if available>> The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  It was of actual medication error due to  incorrect product storage.  No adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy is unknown. <<Outcome of the pregnancy was reported as <Birth Type unknown> and fetal outcome was reported as Unknown.>>  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Anxiety, Atelectasis, Chest X-ray abnormal, Dyspnoea
Clinical narrative: Patient is an 85 y/o male with PMH significant for HFrEF, CAD s/p CABG, Afib s/p ICD, AAA, T2DM, HTN, HLD, asthma, OSA, and hypogonadism. Patient had HBPC visit on 1/7/19 where his second Shingrix dose was administered. Admitted the next day after receiving the vaccine with complaints of sudden onset of SOB, nausea, and a sense of impending doom. Patient also reported having urinary incontinence, new onset L abdominal pain, and difficulty sleeping. Workup was unrevealing so it was determined to be an adverse reaction to Shingrix. Discharged after one day in stable condition without precautions since he had completed his Shingrix schedule. NauseaVomiting & shortness of breath, sense of impending doom, abdominal pain, urinary incontinence, difficulty sleeping, observation.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Urinary incontinence, Vomiting
Clinical narrative: Patient is an 85 y/o male with PMH significant for HFrEF, CAD s/p CABG, Afib s/p ICD, AAA, T2DM, HTN, HLD, asthma, OSA, and hypogonadism. Patient had HBPC visit on 1/7/19 where his second Shingrix dose was administered. Admitted the next day after receiving the vaccine with complaints of sudden onset of SOB, nausea, and a sense of impending doom. Patient also reported having urinary incontinence, new onset L abdominal pain, and difficulty sleeping. Workup was unrevealing so it was determined to be an adverse reaction to Shingrix. Discharged after one day in stable condition without precautions since he had completed his Shingrix schedule. NauseaVomiting & shortness of breath, sense of impending doom, abdominal pain, urinary incontinence, difficulty sleeping, observation.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: It appears that pt. had a reaction to the MMR vaccine given her and had no other symptoms than the non-pruritic rash. f/u prn. Brother came back negative for Measles.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Rash, Rash papular, Skin lesion
Clinical narrative: Pt presented on 4/25/19 to Immunization clinic with lesions s/p varicella vaccine that was administered on Tuesday 4/23/19.  Pt stated that she was working where a child who had gone on vacation and parents said that child was dx with chickenpox while gone.  Pt stated she may have been exposed to them prior to receiving the vaccine.  Provider evaluated pt with mild erythematous papules on legs and local reaction to left posterior upper arm about 3x5 cm in diameter presenting as erythema with no induration or warmth.  Prescribed Benadryl to pt and for pt to take ibuprofen at home if she needed it and to not return to work until lesions are cleared.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: 11x13 erythema on left anterior thigh. Warm to touch. Low fever with body aches and general malaise.
Age: 0.33
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Dysphagia, Eye movement disorder
Clinical narrative: I am a medical physician, Radiation oncologist, mother of 6 (all five before completely vaacinated).  I never thought twice about any harmful effects of vaacines and as a MD, naturally vaacinated my baby according to schedule.  He was bright, happy, talkative with constant babbling, engaging with older siblings, etc.  Immediately after the vaacine (Dtap and MMR) he was fussy and withdrawn.  I figured that might be normal for a few hours or a day but it got worse.  NO LANGUAGE OR BABBLING WHATSOEVER.  It was literally like our little boy was just gone...like he was just a shell.  No interaction, eye contact, developmental milestones, personality...nothing!  He had fevers and they resolved after several days but he remained withdrawn for 3 weeks.  Then I researched this situation and provided extra vitamins in his formula (who knows if that had any impact) but he began, as if developing from the beginning, from scratch, to slowly reengage for periods of time.  Like we would all get short glimpses of the child we knew.  Then more and more, he just seemed to recover and now he is meeting all neurologic/developmental milestones and seems at 21 months to be "normal."  I finally have the time and felt compelled to add this to your data base all this time later.  It was so scary and really devastating and fortunately short lived.  I will not vaacinate him any further.  The risk far outweighs the potential benefit in this sweet baby boy!  As a medical licensed, practicing full time physican, mother of 5 other vaacinated children, non-conspirist type person, and medical director of the Care Center,  I feel very strongly that I am qualified to say and a reliable testimony to say that this reaction was absolutely the cause of something in one of those vaacines.   As a parent it was terrifying and profound.  I have no idea why he recovered his functioning but our family is so thankful he did.  It may be helpful to know that he was delivered by C-section because of a fibroid I had (nothing developmentally wrong with him), 3 weeks early.   Also two of my kids are my step kids and it may be helpful to know that one of them (the boy, now 17 years old) has high functioning autism.  I don't know if either of these factors predisposed patient to these reactions or not.  I received no vaacinations whatsoever during pregnancy.
Age: 0.33
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Flushing, Immediate post-injection reaction, Irritability, Personality disorder, Pyrexia
Clinical narrative: I am a medical physician, Radiation oncologist, mother of 6 (all five before completely vaacinated).  I never thought twice about any harmful effects of vaacines and as a MD, naturally vaacinated my baby according to schedule.  He was bright, happy, talkative with constant babbling, engaging with older siblings, etc.  Immediately after the vaacine (Dtap and MMR) he was fussy and withdrawn.  I figured that might be normal for a few hours or a day but it got worse.  NO LANGUAGE OR BABBLING WHATSOEVER.  It was literally like our little boy was just gone...like he was just a shell.  No interaction, eye contact, developmental milestones, personality...nothing!  He had fevers and they resolved after several days but he remained withdrawn for 3 weeks.  Then I researched this situation and provided extra vitamins in his formula (who knows if that had any impact) but he began, as if developing from the beginning, from scratch, to slowly reengage for periods of time.  Like we would all get short glimpses of the child we knew.  Then more and more, he just seemed to recover and now he is meeting all neurologic/developmental milestones and seems at 21 months to be "normal."  I finally have the time and felt compelled to add this to your data base all this time later.  It was so scary and really devastating and fortunately short lived.  I will not vaacinate him any further.  The risk far outweighs the potential benefit in this sweet baby boy!  As a medical licensed, practicing full time physican, mother of 5 other vaacinated children, non-conspirist type person, and medical director of the Care Center,  I feel very strongly that I am qualified to say and a reliable testimony to say that this reaction was absolutely the cause of something in one of those vaacines.   As a parent it was terrifying and profound.  I have no idea why he recovered his functioning but our family is so thankful he did.  It may be helpful to know that he was delivered by C-section because of a fibroid I had (nothing developmentally wrong with him), 3 weeks early.   Also two of my kids are my step kids and it may be helpful to know that one of them (the boy, now 17 years old) has high functioning autism.  I don't know if either of these factors predisposed patient to these reactions or not.  I received no vaacinations whatsoever during pregnancy.
Age: 0.33
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Seizure like phenomena, Social avoidant behaviour
Clinical narrative: I am a medical physician, Radiation oncologist, mother of 6 (all five before completely vaacinated).  I never thought twice about any harmful effects of vaacines and as a MD, naturally vaacinated my baby according to schedule.  He was bright, happy, talkative with constant babbling, engaging with older siblings, etc.  Immediately after the vaacine (Dtap and MMR) he was fussy and withdrawn.  I figured that might be normal for a few hours or a day but it got worse.  NO LANGUAGE OR BABBLING WHATSOEVER.  It was literally like our little boy was just gone...like he was just a shell.  No interaction, eye contact, developmental milestones, personality...nothing!  He had fevers and they resolved after several days but he remained withdrawn for 3 weeks.  Then I researched this situation and provided extra vitamins in his formula (who knows if that had any impact) but he began, as if developing from the beginning, from scratch, to slowly reengage for periods of time.  Like we would all get short glimpses of the child we knew.  Then more and more, he just seemed to recover and now he is meeting all neurologic/developmental milestones and seems at 21 months to be "normal."  I finally have the time and felt compelled to add this to your data base all this time later.  It was so scary and really devastating and fortunately short lived.  I will not vaacinate him any further.  The risk far outweighs the potential benefit in this sweet baby boy!  As a medical licensed, practicing full time physican, mother of 5 other vaacinated children, non-conspirist type person, and medical director of the Care Center,  I feel very strongly that I am qualified to say and a reliable testimony to say that this reaction was absolutely the cause of something in one of those vaacines.   As a parent it was terrifying and profound.  I have no idea why he recovered his functioning but our family is so thankful he did.  It may be helpful to know that he was delivered by C-section because of a fibroid I had (nothing developmentally wrong with him), 3 weeks early.   Also two of my kids are my step kids and it may be helpful to know that one of them (the boy, now 17 years old) has high functioning autism.  I don't know if either of these factors predisposed patient to these reactions or not.  I received no vaacinations whatsoever during pregnancy.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain at injection site, redness, swelling , itching
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: About 1o minutes after receiving the shot, while driving home, I became very dizzy. Symptoms similar to Vertigo. I pulled the car to the side of the road and waited 15 minutes. Went to the Hospital ER. Because I have a Pacemaker, they sent me to Hospital. I stayed overnight. They could not confirm that my reaction had anything to do with the shot.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: PATIENT PRESENTED TO PHARMACY AFTER 2 DAYS OF PNEUMOVAX ADMINISTERED AND STATED HIS ARM WAS SWOLLEN AND REDNESS AROUND THE AREA OF INJECTION, HE ALSO STATED THAT HE HAD FEVER.  I ADVISED TO PATIENT TAKE IBUPROFEN AND IF ARM GETS WORSE TO CONTACT HIS PRIMARY CARE PHYSICIAN
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hot flush, Loss of consciousness, Urinary incontinence
Clinical narrative: Upon awakening experienced dizziness, hot flashes, passed out and unconsciously urinated herself. No known treatment. Full recovery. Dr was made aware according to patient and could still get 2nd vaccine later, but patient says will not get it
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Hyperaesthesia, Inflammation, Mobility decreased, Pain
Clinical narrative: Patient started having limited mobility, soreness, inflammation, pain, discomfort and sensitive touching the area the day after (3/1/2019) administration of Shingrix. The patient used naproxen as needed and did consult with an occupational therapist but both had limited benefit to his symptoms, not knowing at the time the vaccination could be a factor. Currently he is about 70% better and is contacting his primary physician.
Age: 0.17
Sex: F
Vaccine: PNC13, RV5
Symptoms: Bacterial infection, Blood test, Eczema, Incisional drainage, Leukocytosis
Clinical narrative: Otitis externa, bacterial infection of neck- treated with Ciprodex suspension / mupirocin topical / hydrocortisone topical for 7 days Fever, leukocytosis, lymph node abscess, lymphadenitis - clindamycin and ceftriaxone through IV for 5 days. Keflex oral started for 10 days total. Incision/drainage of lymph node abscess Ezcema/rash on face.
Age: 0.17
Sex: F
Vaccine: PNC13, RV5
Symptoms: Lymph node abscess, Lymphadenitis, Otitis externa, Pyrexia, Rash
Clinical narrative: Otitis externa, bacterial infection of neck- treated with Ciprodex suspension / mupirocin topical / hydrocortisone topical for 7 days Fever, leukocytosis, lymph node abscess, lymphadenitis - clindamycin and ceftriaxone through IV for 5 days. Keflex oral started for 10 days total. Incision/drainage of lymph node abscess Ezcema/rash on face.
Age: 0.17
Sex: F
Vaccine: PNC13, RV5
Symptoms: Ultrasound scan
Clinical narrative: Otitis externa, bacterial infection of neck- treated with Ciprodex suspension / mupirocin topical / hydrocortisone topical for 7 days Fever, leukocytosis, lymph node abscess, lymphadenitis - clindamycin and ceftriaxone through IV for 5 days. Keflex oral started for 10 days total. Incision/drainage of lymph node abscess Ezcema/rash on face.
Sex: F
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: The patient presented last week with mumps; This spontaneous report was received from a physician regarding a female patient of 18 months old. The patient's concurrent condition, drug reactions/allergies, medical history and concomitant therapy were not reported.  On unspecified date in October 2018 (reported as "approximately 6 months ago"), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dosage, rout of administration, lot number and expiration date were not provided) to  prevent measles, mumps, rubella (prophylaxis). The sterile diluent was reported.   On unknown date in April 2019 (reported as "last weekend"), the patient presented with mumps.  She received sought medical attention. The physician reported this was a clinical diagnosis, treatment was no given and lab test were not performed to confirm the diagnosis.  The outcome of the event was not reported. The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was reported as unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects; A 52 years old patient was inadvertentlyadministered a dose of PROQUAD instead of M-M-R II; A 52 years old patient was inadvertentlyadministered a dose of PROQUAD instead of M-M-R II; This spontaneous report was received from a medical assistant regarding a 52-year-old patient. The patient's concurrent conditions, drug reactions/allergies, medical history and concomitant therapies were not reported.  On 25-APR-2019, the patient was administered inadvertently Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) subcutaneous lot number R013126 and expiration date 04-NOV-2019 (dosage was not reported) for prophylaxis instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Inappropriate age at vaccine administration ) and (Wrong vaccine administered ). No adverse effects were reported. The sterile diluent was reported.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Fatigue, Hyperhidrosis, Influenza like illness, Lethargy
Clinical narrative: flu-like symptoms; right arm heavy and sore; right arm heavy and sore; clammy and sweaty; sweaty; lethargic; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago).   On 16th April 2019 19:00, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, 8 hrs after receiving Shingrix, the patient experienced pain in arm, heaviness in arm, clamminess, sweating, lethargy and fatigue. On 18th April 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the heaviness in arm, clamminess, sweating, lethargy, fatigue and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm, heaviness in arm, clamminess, sweating, lethargy, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On 16th April 2019 about 7 pm  the patient was vaccinated with 2nd dose of Shingrix. The patient experienced pain in arm and heaviness in arm after 8 hours of vaccination. The patient also experienced clamminess, sweating, lethargy and fatigue. On 18th April 2019, the patient experienced influenza-like symptoms. The patient was feeling fine at the time of reporting.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: flu-like symptoms; right arm heavy and sore; right arm heavy and sore; clammy and sweaty; sweaty; lethargic; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago).   On 16th April 2019 19:00, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, 8 hrs after receiving Shingrix, the patient experienced pain in arm, heaviness in arm, clamminess, sweating, lethargy and fatigue. On 18th April 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the heaviness in arm, clamminess, sweating, lethargy, fatigue and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm, heaviness in arm, clamminess, sweating, lethargy, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On 16th April 2019 about 7 pm  the patient was vaccinated with 2nd dose of Shingrix. The patient experienced pain in arm and heaviness in arm after 8 hours of vaccination. The patient also experienced clamminess, sweating, lethargy and fatigue. On 18th April 2019, the patient experienced influenza-like symptoms. The patient was feeling fine at the time of reporting.
Age: 68.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Condition aggravated, Drug ineffective, Herpes simplex, Pain
Clinical narrative: Lack of drug effect; Outbreak of herpes simplex virus 1; Condition aggravated; Pain; This case was reported by a consumer via call center representative and described the occurrence of lack of drug effect in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for herpes simplex type i.   Concurrent medical conditions included herpes simplex type i.   On 9th April 2019, the patient received Shingrix. On an unknown date, the patient started Valacyclovir 500 mg at an unknown frequency. On 12th April 2019, 3 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced herpes simplex type i, condition aggravated and pain. On an unknown date, the patient experienced lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the lack of drug effect, herpes simplex type i, condition aggravated and pain were unknown.   It was unknown if the reporter considered the herpes simplex type i, condition aggravated and pain to be related to Shingrix. It was unknown if the reporter considered the lack of drug effect to be related to Valacyclovir.  Additional case details were reported as follows: The patient received Shingrix vaccine in left arm. Patient did not know the route of administration. Patient had terrible outbreak of herpes simplex virus 1 with pain.  The patient had a prescription of Valacyclovir (manufacturer not specified). The patient took 2 doses of Valacyclovir and as per patient "that was not enough", then took 4 doses of Valacyclovir and "that was not enough" which led to lack of drug effect. Then the patient took 6 doses for 4 days, which helped it to calm down.  The prescribed dose was not specified. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Drug hypersensitivity, Pharyngeal swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a 65-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Concurrent medical conditions included egg allergy, fish allergy and shellfish allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced throat swelling and documented allergy to administered drug. On an unknown date, the outcome of the throat swelling and documented allergy to administered drug were unknown. The reporter considered the throat swelling and documented allergy to administered drug to be possibly related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: Age at vaccination was not reported. The patient had a reaction to the flu vaccine once where her throat swelled up, and she thought it was related to the egg content. The patient has an egg allergy and her throat swells up if she eats eggs. It was unknown whether the flu vaccine was a GSK product.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash, seen by MD on  4/25/19 advised .  hydrate, continue with tylenol. if rash, worsens, spreads, fever >100.4-104, koplik spots. Inform to call/head to ER.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Dyspepsia, Influenza like illness, Lethargy
Clinical narrative: "Upset stomach/indigestion, achiness in neck and upper back, and flu-like symptoms/lethargy" per patient. Symptoms resolved on their own by 4/21/19. No treatment was taken.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: "Upset stomach/indigestion, achiness in neck and upper back, and flu-like symptoms/lethargy" per patient. Symptoms resolved on their own by 4/21/19. No treatment was taken.
Age: 1.67
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Injection site erythema, Injection site rash, Pyrexia, Rash
Clinical narrative: Patient developed fever, diarrhea, and rash that spread to her trunk. A day later the rash spread to her face, ears, and extremities. There was redness at the injection site, then spread into a rash. Provider prescribed Acetaminophen, cetirizine, and diphenhydramine. Patient came back into clinic 4/25/2019. All symptoms had improved except the rash which was almost resolved at that time.
Age: 52.0
Sex: F
Vaccine: MMRV, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Low grade fever (99.6) , Headaches , pain in joints throughout body , moderate paint at injection site on right arm , swelling and redness at injection site on right arm , nausea , fatigue .
Age: 52.0
Sex: F
Vaccine: MMRV, VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Low grade fever (99.6) , Headaches , pain in joints throughout body , moderate paint at injection site on right arm , swelling and redness at injection site on right arm , nausea , fatigue .
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood pressure increased, Dizziness, Heart rate increased, Muscle tightness
Clinical narrative: patient experience extreme muscle tightness around hip area, and severe back pain, dizziness, blurred vision, increase heart rate,  patient was monitor for sign of anaphylaxis , pt have no sign and symptom of anaphylaxis, 2 minutes after reaction, patient felt no more tightness, pain go away, heart feels normal, patient was monitor for 30 minutes, blood pressure was taken, 141/91, patient have high blood pressure and forgot to take medication in the morning, advise pt to take medication as soon as possible, patient state no more blurred vision, no more dizziness, no other adverse reaction, advise patient to go to pcp, and advise patient to come back at 5 pm to check blood pressure,
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Vision blurred
Clinical narrative: patient experience extreme muscle tightness around hip area, and severe back pain, dizziness, blurred vision, increase heart rate,  patient was monitor for sign of anaphylaxis , pt have no sign and symptom of anaphylaxis, 2 minutes after reaction, patient felt no more tightness, pain go away, heart feels normal, patient was monitor for 30 minutes, blood pressure was taken, 141/91, patient have high blood pressure and forgot to take medication in the morning, advise pt to take medication as soon as possible, patient state no more blurred vision, no more dizziness, no other adverse reaction, advise patient to go to pcp, and advise patient to come back at 5 pm to check blood pressure,
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Influenza like illness, Joint stiffness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: SX's started at 7 pm...stiffness in neck, then to all muscles and joins flu like sx's  through bedtime  on 4/24/19 diarrhea 4/24 at 11:30 am - 1:30 pm  same day slight tingling in random sites on body
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Disorientation, Eye movement disorder, Fall
Clinical narrative: Patient received vaccine and left our clinic  with father and went to the bank.  About 10 minutes after receiving the vaccine, while in the bank, per the father, "my son fell on the ground and had a seizure".  Patient hit his head on the floor when he fell.  Father estimates the patient was conscious again after 30 seconds but slightly disoriented.  Father put the patient back in the car and drove him the 2 minutes back to our clinic. On the way back to the clinic, father described a second episode that lasted 10 seconds with "shaking and eyes rolled back"  When they entered the clinic, patient vomited in the lobby and was taken back for evaluation by MD and nurse. MD felt that patient had a syncope episode with vasalvagal trigger. Pt was sent to the ER to rule out seizure and head injury,
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Head injury, Loss of consciousness, Presyncope, Seizure, Syncope
Clinical narrative: Patient received vaccine and left our clinic  with father and went to the bank.  About 10 minutes after receiving the vaccine, while in the bank, per the father, "my son fell on the ground and had a seizure".  Patient hit his head on the floor when he fell.  Father estimates the patient was conscious again after 30 seconds but slightly disoriented.  Father put the patient back in the car and drove him the 2 minutes back to our clinic. On the way back to the clinic, father described a second episode that lasted 10 seconds with "shaking and eyes rolled back"  When they entered the clinic, patient vomited in the lobby and was taken back for evaluation by MD and nurse. MD felt that patient had a syncope episode with vasalvagal trigger. Pt was sent to the ER to rule out seizure and head injury,
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Tremor, Vomiting
Clinical narrative: Patient received vaccine and left our clinic  with father and went to the bank.  About 10 minutes after receiving the vaccine, while in the bank, per the father, "my son fell on the ground and had a seizure".  Patient hit his head on the floor when he fell.  Father estimates the patient was conscious again after 30 seconds but slightly disoriented.  Father put the patient back in the car and drove him the 2 minutes back to our clinic. On the way back to the clinic, father described a second episode that lasted 10 seconds with "shaking and eyes rolled back"  When they entered the clinic, patient vomited in the lobby and was taken back for evaluation by MD and nurse. MD felt that patient had a syncope episode with vasalvagal trigger. Pt was sent to the ER to rule out seizure and head injury,
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt called today complaining of swelling and pain at injection site
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Balance disorder, Constipation, Erythema, Feeling abnormal, Feeling hot
Clinical narrative: Pt called today complaining of swelling and pain at injection site
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myalgia, Nausea, Pain, Swelling
Clinical narrative: Pt called today complaining of swelling and pain at injection site
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain in arm that has continued 45 days after vaccine. Bursitis potentially. Patient has difficulty raising arm and pain when he lifts it too high and crosses his body.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red , slight warm, sore and swollen at injection site.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Heart rate irregular
Clinical narrative: Patient stated the day after vaccination she has shortness of breath and irregular heart beat.  She is still feeling difficulty breathing and heart rate irregularity as of today.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Decreased appetite, Feeling cold, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: tingling in my finger, toes, my pinky and ring finger went numb on my right hand for several hours , cold spurting sensation on the sides of my tongue, hands and feet and wrists,numb lips , numb spots on my face, large hives , loss of appetite still on going. I haven't gotten the rest of the shots because , I can't find a doctor who will even talk to me about all of this
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Peripheral coldness, Urticaria
Clinical narrative: tingling in my finger, toes, my pinky and ring finger went numb on my right hand for several hours , cold spurting sensation on the sides of my tongue, hands and feet and wrists,numb lips , numb spots on my face, large hives , loss of appetite still on going. I haven't gotten the rest of the shots because , I can't find a doctor who will even talk to me about all of this
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Currently 32 weeks pregnant due 6/20/19. Pregnancy #3. Awoke at 3 a.m. the night after receiving the vaccination with severe joint pain throughout my entire body, as well as headache, nausea and fever of 102. Took 1000 mg acetaminophen, and symptoms subsided, but were not resolved, temperature dropped to 99.8. Awoke again at 6 a.m. completely soaked in sweat, and body aches were back. Was seen by Primary Care doctor at 11 a.m., and administered two liters of IV fluid, zofran, and acetaminophen. Flu test was negative in blood results were normal. I was sent home after receiving fluids.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza virus test negative, Nausea, Pain, Pyrexia
Clinical narrative: Currently 32 weeks pregnant due 6/20/19. Pregnancy #3. Awoke at 3 a.m. the night after receiving the vaccination with severe joint pain throughout my entire body, as well as headache, nausea and fever of 102. Took 1000 mg acetaminophen, and symptoms subsided, but were not resolved, temperature dropped to 99.8. Awoke again at 6 a.m. completely soaked in sweat, and body aches were back. Was seen by Primary Care doctor at 11 a.m., and administered two liters of IV fluid, zofran, and acetaminophen. Flu test was negative in blood results were normal. I was sent home after receiving fluids.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Rash generalised
Clinical narrative: Full body Rash for 3 days. No fever. Jo sign of other illness.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Epistaxis, Urticaria
Clinical narrative: Mom called and left a message at 2:16 PM informing me that at approximately 2:15 PM upon leaving our clinic parking lot that her daughter had 2  hives pop up around her mouth.  I was able to call mom back around 3:15 PM, she then stated that patient had gotten hives around her mouth before after certain foods like eggs and dairy, and bell-peppers make her lips swell up.  Mom stated that she would medicate patient once they got home with Benadryl if things got worse as this as helped with her allergic reactions in the past.  I called and spoke with my supervisor regarding what happened at approximately 3:45 PM. I called back and spoke with child's mom regarding her condition at 4:15 pm, she stated that her daughter had a bloody nose but that her hives were getting smaller.  I reminded her to watch for any breathing issues and call 911 if necessary or go to E.R.  Mom stated that patient had a bloody nose earlier today too before being vaccinated, from the dry air she believes.  I then told her to medicate with Benadryl if hives worsen or seek out care at an urgent care clinic this weekend if necessary.  I told mom that I would be filling out a VAERS report for the incident, and to check with her child's pediatrician before vaccinating her again with MMR vaccine.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: After injection of Shingrix,  I developed very bad side effect symptoms which include muscle ache, flu like symptoms, fever as high as 101.5 F.  Pain at the arm, headache, upset stomach. and tiredness.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: After injection of Shingrix,  I developed very bad side effect symptoms which include muscle ache, flu like symptoms, fever as high as 101.5 F.  Pain at the arm, headache, upset stomach. and tiredness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: patient developed very red arm-was treated by doctor  on april 26 -diagnosis of cellulitis by md -was given prescription of keflex
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT ARRIVED WITH A SWELLING ON THE RIGHT MIDDLE ASPECT OF THE THIGH. MOTHER STATED THERE WAS PAIN. WARMTH AND REDNESSED ASSESSED, PT WAS AFEBRILE.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: L thigh (injection site) with swelling, erythema, induration, and small number of bullae over injection site. Extended ~ 8 inches in diameter. No bleeding, petechiae. No systemic symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Nothing has been. Done.  Warm to touch, very tender red circle is about the size of a grapefruit.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Varicella
Clinical narrative: Approx 30 hrs after injection, a Singles/Chicken Pox rash developed under the arm (arm and chest) area of the same arm that was vaccinated.  The area was  approximately the 6  inches around on both the arm and chest.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: Received as recommended during pregnancy, due date 07/04/2019. No previous complications. Extreme headache and fatigue. Temperature of 100.3.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Rash morbilliform
Clinical narrative: Day 1 - Fever up to 102, Light red prickly rash on belly, chest, back, neck, and head.   Day 2 - Fever up to 99.9, Darker more extensive red prickly rash on belly, chest, back, neck, head, in and around ears. Lighter red prickly rash on arms and legs. Saw immunologist for scheduled appointment, he said it looked like a text book measles rash.
Age: 3.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: No adverse event, Vaccination error
Clinical narrative: - Vaccine administration error,  - No adverse effects noted by RN and declined by parent (mother).   - vaccine administered by RN.  - Provider & Guardian notified. - Parent declines additional dose at this time  - Addressed error with staff and steps implemented to ensure this error does not occur again.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature, Eye movement disorder, Irritability, Seizure like phenomena, Skin discolouration
Clinical narrative: projectile vomiting, temp, fussy, parent said eyes rolled back lasting 30 seconds. Approximately 2 hours after vaccinations symptoms appeared. During the episode her skin turned grayish, clicking sounds with tongue. Seizure like activity.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Tongue disorder, Vomiting projectile
Clinical narrative: projectile vomiting, temp, fussy, parent said eyes rolled back lasting 30 seconds. Approximately 2 hours after vaccinations symptoms appeared. During the episode her skin turned grayish, clicking sounds with tongue. Seizure like activity.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Vomiting and headache ->redness, enduration, warmth. Tenderness at injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Vomiting and headache ->redness, enduration, warmth. Tenderness at injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Rt upper arm with moderate warmth, redness over the proximal 1/3rd of Deltoid Region, and edema that is most noticeable over the distal 1/3rd of dorsal upper arm. Diameter of Rt upper arm distal portion is 28cm compared to Lt distal upper arm 26.5cm. No dyspnea
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Erythema, Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: Patient saw spots, laid down. Felt nauseous and face became red developed rash on cheeks. Vitals signs stable before, during and after. Seen by doctor had sweaty palms, chest felt heavy. Rested for 15mins - 30mins. Ice pack and water given. Patient was well and left office