chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Anxiety, Dizziness, Headache, Nervousness, Paraesthesia
Clinical narrative: incredible headache; Vomiting; Dizziness; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; This is a spontaneous report from a contactable registered nurse. A 16-year-old male patient received second dose of meningococcal group b rlp2086 (TRUMENBA, suspension for injection, NDC number: 005-0100-10, Batch/lot number: AM6864, Expiry Date: Mar2021, strength: 0.5 ml), intramuscularly on 13Aug2019 at 0.5ml single in prefilled syringe given intramuscular in the left deltoid for vaccination to complete his series. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of meningococcal group b rlp2086 for immunization on an unspecified date. On 13Aug2019, the patient experienced incredible headache, vomiting, and dizziness. The patient was in the office for a bit after the shot. The patient drove for about 20 minutes after leaving the office and then had to pull off to the side of the road because he experienced an incredible headache, vomiting, and dizziness. The patient had tingling in his hands and the electronic medical system (EMS) thought it was from anxiety and his nerves from feeling this way, from Aug2019. The outcome of events incredible headache, vomiting and dizziness was resolved on 13Aug2019, and outcome of the other events was unknown. Reporter considered seriousness for events incredible headache, vomiting, dizziness as medically significant.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of events incredible headache, vomiting, dizziness cannot be excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product.  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.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: incredible headache; Vomiting; Dizziness; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; This is a spontaneous report from a contactable registered nurse. A 16-year-old male patient received second dose of meningococcal group b rlp2086 (TRUMENBA, suspension for injection, NDC number: 005-0100-10, Batch/lot number: AM6864, Expiry Date: Mar2021, strength: 0.5 ml), intramuscularly on 13Aug2019 at 0.5ml single in prefilled syringe given intramuscular in the left deltoid for vaccination to complete his series. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of meningococcal group b rlp2086 for immunization on an unspecified date. On 13Aug2019, the patient experienced incredible headache, vomiting, and dizziness. The patient was in the office for a bit after the shot. The patient drove for about 20 minutes after leaving the office and then had to pull off to the side of the road because he experienced an incredible headache, vomiting, and dizziness. The patient had tingling in his hands and the electronic medical system (EMS) thought it was from anxiety and his nerves from feeling this way, from Aug2019. The outcome of events incredible headache, vomiting and dizziness was resolved on 13Aug2019, and outcome of the other events was unknown. Reporter considered seriousness for events incredible headache, vomiting, dizziness as medically significant.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of events incredible headache, vomiting, dizziness cannot be excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product.  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.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Axillary pain, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Approximately 10 hours after administration pain and stiffness in Armpit area.   Minor ache at injection site on arm  I began massaging the armpit area during the night and it helped to diffuse the pain and is somewhat more tolerable this being the next day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M decreased, Differential white blood cell count normal, Erythema, Full blood count normal
Clinical narrative: Itching, sharp pain, swelling, intense erythema,  superficial skin sloughing ~5 cm in diameter evolving over the course of a month.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Monocyte count increased, Pain, Pruritus, Skin exfoliation
Clinical narrative: Itching, sharp pain, swelling, intense erythema,  superficial skin sloughing ~5 cm in diameter evolving over the course of a month.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Itching, sharp pain, swelling, intense erythema,  superficial skin sloughing ~5 cm in diameter evolving over the course of a month.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Joint swelling, Muscle spasms
Clinical narrative: Two days in bed: high fever, sweating/chills, headache, nausea, sever leg muscle pain and cramps.  After two days of this, I then had a severe swollen knee. I was given 5 day course of steroids for the inflammation.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, X-ray limb
Clinical narrative: Two days in bed: high fever, sweating/chills, headache, nausea, sever leg muscle pain and cramps.  After two days of this, I then had a severe swollen knee. I was given 5 day course of steroids for the inflammation.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test normal, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: the patient was administered GARDASIL on 25-FEB-2019 and on 26-APR-2019 and the patient discovered she was pregnant; This spontaneous prospective pregnancy report was received from a medical assistant and refers to a 21-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 25-FEB-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, lot # R005341, expiration date: 06-DEC-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. On 26-APR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, lot # R005341, expiration date: 06-DEC-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. On 20-MAY-2019, the patient received medroxyprogesterone acetate (DEPO-PROVERA) shot. On an unknown date, the patient discovered she was pregnant. On 11-JUL-2019, a pelvic ultrasound was performed and showed viable uterine pregnancy 21 weeks and 5 days. Last menstrual period (LMP) was calculated based on gestational age at pelvic ultrasound as 09-FEB-2019, estimated date of conception (EDC) was estimated on 23-FEB-2019 and estimated date of delivery (EDD) was 16-NOV-2019. Gestation period at exposure was 16 days and 75 days. On an unknown date in 2019, unspecified blood work was performed with normal result. The pregnancy outcome was outcome pending and fetal outcome was unknown.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received unspecified dose o VARIVAX with MMR II / VARlVAX was improperly stored.; This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 01-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX)  injection, (lot # R020673, expiry date 18-JUL-2020; exact dose, route of administration and injection site were not provided) for prophylaxis. On the same date, the patient also received properly stored dose of measles virus vaccine live (enders-edmonston), mumps virus vaccine live (jeryl lynn), rubella virus vaccine live (wistar ra 27/3) (M-M-R II) injection(lot # N025897, expiry date 19-SEP-2019, albumin status rHa; exact dose, route of administration and injection site were not provided) also for prophylaxis. The vaccines were reconstituted with sterile diluent (lot # and expiry date were not provided). The varicella virus vaccine live (Oka/Merck)(VARIVAX) was exposed to a temperature of 8.6 Fahrenheit degrees (F) for 1 hour and 36 minutes. Previous temperature excursion included exposition to 6.1 F for 1 hour and 42 minutes. The first temperature excursion started on 27-JUL-2019. Digital data logger was involved. No adverse effects were reported.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Pregnancy test urine
Clinical narrative: Patient was vaccinated with M-M-R II and subsequently became pregnant; This spontaneous prospective pregnancy report was received from a medical assistant referring to a currently 31 year old female primigravida patient, with no drug reactions/allergies.  Concomitant therapies included docusate sodium (COLACE), ferrous sulfate and prenatal iron.   On an unspecified date, the patient underwent an insertion procedure with etonogestrel implant (NEXPLANON), subdermally, for an unknown indication (strength, frequency, lot number and expiration date were not reported) (events capturen in case 1908USA002450).   On 19-JUN-2019, the patient had her last menstrual period (LMP).  On 22-JUN-2019, the patient had the etonogestrel implant (NEXPLANON) rod removed.  On the same day, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (recombinant human albumin), lot # R029513, expiring on 14-OCT-2020, dose 1, subcutaneous for prevention due to high local outbreak of measles.    On 20-JUL-2019, the patient saw an unspecified doctor, for medical attention, because she was not getting her menses and it was determined during the office visit that the patient was pregnant (unspecified method) (drug exposure before pregnancy).  On an unspecified date, a urine pregnancy test was performed (result not provided).   The patient's estimated due date (EDD) was of 25-MAR-2020.    At the time of the report, the pregnancy outcome was pending.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1908USA002450:
Age: 79.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Headache, Intertrigo, Off label use
Clinical narrative: GARDASIL 9 used for the treatment of condyloma acuminata (off label use); Literature report:   This literature marketed report has been received from the authors of the published article, and refers to a 79-year-old female patient with severe Parkinson's disease. On an unknown date, the patient presented with numerous massive coalescing verrucous papules and plaques in the groin and inframammary folds (extensive verrucous papules and plaques in the pubis, inner thighs, and left inguinal fold). Lesions had been present for years and were accompanied by itching, maceration, and malodor. Biopsy from a few lesions demonstrated papillomatosis and acanthosis of the epidermis, together with koilocytic cells in the upper parts of the epidermis. In situ hybridization detected positivity for high-risk HPV 16 and 18 and low-risk 6 and 11 but was negative for HPV 31 and 33 types. No atypia was found in the epidermal cells, and histopathological diagnosis of condyloma acuminata was established. Surgical treatment was considered but was deferred due to the extensive lesions and possibility of long recovery. Additionally, the patient was wheelchair bound and was not able to take care of the wounds. Few applications of imiquimod caused significant irritation, and the patient stopped it. Off-label treatment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine was discussed.  On an unknown date, the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was injected intramuscularly (exact dose, lot # and expiration date were not reported) (off label use).  The patient experienced dizziness, headache, and fatigue in the evening after the injections and was admitted to a hospital. Although unable to prove that the episode was directly related to the vaccine and not caused by other reasons (exacerbation of Parkinson's symptoms, vasovagal, other medication effect, etc.), she refused to have additional doses of the vaccine in the future (only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered). The patient was followed during the year and was only given supportive topical medications (topical hydrocortisone and antifungals) to treat maceration and itching in the folds as well as superimposed intertrigo. With every subsequent visit, it was noticed that condylomas were diminishing in size and completely disappeared 1.5 years after the initial visit.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 79.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Pruritus, Skin maceration, Therapeutic response unexpected
Clinical narrative: GARDASIL 9 used for the treatment of condyloma acuminata (off label use); Literature report:   This literature marketed report has been received from the authors of the published article, and refers to a 79-year-old female patient with severe Parkinson's disease. On an unknown date, the patient presented with numerous massive coalescing verrucous papules and plaques in the groin and inframammary folds (extensive verrucous papules and plaques in the pubis, inner thighs, and left inguinal fold). Lesions had been present for years and were accompanied by itching, maceration, and malodor. Biopsy from a few lesions demonstrated papillomatosis and acanthosis of the epidermis, together with koilocytic cells in the upper parts of the epidermis. In situ hybridization detected positivity for high-risk HPV 16 and 18 and low-risk 6 and 11 but was negative for HPV 31 and 33 types. No atypia was found in the epidermal cells, and histopathological diagnosis of condyloma acuminata was established. Surgical treatment was considered but was deferred due to the extensive lesions and possibility of long recovery. Additionally, the patient was wheelchair bound and was not able to take care of the wounds. Few applications of imiquimod caused significant irritation, and the patient stopped it. Off-label treatment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine was discussed.  On an unknown date, the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was injected intramuscularly (exact dose, lot # and expiration date were not reported) (off label use).  The patient experienced dizziness, headache, and fatigue in the evening after the injections and was admitted to a hospital. Although unable to prove that the episode was directly related to the vaccine and not caused by other reasons (exacerbation of Parkinson's symptoms, vasovagal, other medication effect, etc.), she refused to have additional doses of the vaccine in the future (only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered). The patient was followed during the year and was only given supportive topical medications (topical hydrocortisone and antifungals) to treat maceration and itching in the folds as well as superimposed intertrigo. With every subsequent visit, it was noticed that condylomas were diminishing in size and completely disappeared 1.5 years after the initial visit.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: fainted and had a seizure immediately following vaccination; fainted and had a seizure immediately following vaccination; This spontaneous report was informed from a company representative who was received information from a physician who refers a female patient who was 18 years old. Her pertinent medical history, concomitant therapies and drug reactions an allergies were unknown by the reporter.    On an unknown date the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection indication reported as vaccination, (Concentration, dose, frequency, route, lot number and expiration date were unknown). following vaccination the patient immediately  fainted (syncope) and had a seizure (seizure). It was unknown by the reporter, if the patient sought medical attention, if laboratory diagnostic or studies were performed or if the patient received any treatment due to the event. The outcome of syncope and seizure was unknown.   The causality assessment between HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration, and the occurred events was not reported.  Upon internal review, syncope and seizure were determined to be medically significant event.
Sex: F
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; A patient received MMR II via intramuscular route.; This spontaneous report was received from a pharmacy intern concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 15-AUG-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) via intramuscular route (incorrect route of product administration), lot # R035701, expiration date 09-DEC-2020 for prophylaxis. The vaccine was reconstituted with sterile diluent (MRK), lot # S003613 and expiration date 22-JUL-2021. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA006764:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cerebrovascular accident, Paraesthesia
Clinical narrative: Acute Cerebrovascular Accident; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered generalized weakness, facial paresthesias, and was ultimately diagnosed with an acute cerebrovascular accident which required hospitalization. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  The event of acute cerebrovascular accident was considered to be disabling by the reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The patient was in mid of 60's. The age at vaccination was not reported. The patient received a full immunization schedule of Shingrix and still got shingles. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test was unknown. No other details provided. The reporter consented to followup.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a medical representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter could not remember any identifiable details other than female who got both doses Shingrix and still got shingles. This case was considered as suspected vaccination failure, as time to onset and laboratory confirmation test were unknown. The reporter consented to follow up.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: feeling very sick; major fatigue; fever; ache in all major joints; sore throat; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fatigue, fever, joint pain and sore throat. On an unknown date, the outcome of the feeling unwell, fatigue, fever, joint pain and sore throat were unknown.   It was unknown if the reporter considered the feeling unwell, fatigue, fever, joint pain and sore throat to be related to Shingrix.  Additional details were received as follows: After receiving 1st dose patient was feeling very sick, major fatigue, fever, ache in all major joints and sore throat. The patient experienced events after receiving 1st dose and asked whether the 2nd dose would be worse or not. The patient asked not to share information. The patient was asked to refer health care provider as primary resource for patient care. The patient was trying to figure out if there was any data indicating that if the first dose was not tolerated well would the second dose be worse. The patient would need to schedule 4 to 5 days of bed.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore at injection site/to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on Saturday and he said that it was sore at the injection site.  The whole region where he received the injection was sore to the touch. The reporter did not consent to follow up. The patient declined answering further questions.
Sex: F
Vaccine: VARZOS
Symptoms: Immobile, Pain
Clinical narrative: pain over the entire body / aches; unable to move from her bed; This case was reported by a consumer via call center representative and described the occurrence of immobile in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 2nd dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced generalized aching. In August 2019, the patient experienced immobile (serious criteria GSK medically significant). On an unknown date, the outcome of the immobile and generalized aching were not recovered/not resolved.   It was unknown if the reporter considered the immobile and generalized aching to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient received Shingrix and was experiencing pain and aches and she was unable to move from her bed.  The pain was over her entire body. In the structural field for source document, the patient's age group was reported as infant, however in the database, it was reported as adult. The reporter consented to follow up.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient came in on 8/16/19 for a Tdap vaccine. I looked into his chart and missed the fact that he had had a Tdap on 8/14/19. Patient stated later that he  had been under the impression that it had been a different vaccine on 8/14/19.  I administered a Tdap vaccine again on 8/16/19 before realizing my mistake.   The incident was discussed with PAC who was on duty on 8/16. He advised on potential side effects possibly being a little stronger but otherwise no health problems were to be expected from the administration of 2 Tdap vaccines only 2 days apart.  Patient was notified of this and voiced understanding. He was advised to back in for evaluation if any problems were to occur. I notified my supervisor of the incident.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Impaired work ability, Influenza like illness, Pain
Clinical narrative: Fever, chills and body ache. Flu-like symptoms. Lasted about 2 days. I missed one day of work but felt pretty awful for about two days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills and body ache. Flu-like symptoms. Lasted about 2 days. I missed one day of work but felt pretty awful for about two days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenitis
Clinical narrative: Cervical Lymphadenitis
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination complication
Clinical narrative: Patient reports that arm was very black and blue after vaccination.  In addition, 4 days after the vaccine on 7/23/2019 patient developed a rash and pain on her back and side, and sought medication care from her PCP who diagnosed her with shingles.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt did get the shingles after getting the vaccine
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Herpes zoster oticus, Increased upper airway secretion, Ophthalmic herpes zoster
Clinical narrative: Roughly a couple weeks after the shingles shot I started feeling tired and got shingles again on the trigeminal nerve on the left side of my face.  (first time  was May 2018 on left side trigeminal nerve).  My doctors and the pharmacist suggested getting the shot because they said shingles can reoccur.   After getting the shot I got a milder case with a small breakout on my ear.  It got in my eye.  I took another round of Valacyclovir.  My eye still acted up.  I took another round of Valacyclovir.  Went on vacation in June and had a major outbreak now in my inner ear, throat and nose.  My doctor now has me on Valacyclovir permanently.    I now have constant pus drainage in my throat and nose.  I now have the threat of going blind, deaf and or cancer.  I know many others who have had adverse reactions to the shingles shot.  in fact most people I know that have had the shot have had some sort of shingles/herpes breakout.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Roughly a couple weeks after the shingles shot I started feeling tired and got shingles again on the trigeminal nerve on the left side of my face.  (first time  was May 2018 on left side trigeminal nerve).  My doctors and the pharmacist suggested getting the shot because they said shingles can reoccur.   After getting the shot I got a milder case with a small breakout on my ear.  It got in my eye.  I took another round of Valacyclovir.  My eye still acted up.  I took another round of Valacyclovir.  Went on vacation in June and had a major outbreak now in my inner ear, throat and nose.  My doctor now has me on Valacyclovir permanently.    I now have constant pus drainage in my throat and nose.  I now have the threat of going blind, deaf and or cancer.  I know many others who have had adverse reactions to the shingles shot.  in fact most people I know that have had the shot have had some sort of shingles/herpes breakout.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Agitation, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactic acid normal, Blood thyroid stimulating hormone normal
Clinical narrative: d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: CSF white blood cell count negative, Carnitine, Ceruloplasmin normal, Computerised tomogram head normal, Disorientation
Clinical narrative: d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Drug screen negative, Electroencephalogram, Encephalitis autoimmune, Enterovirus test negative, HIV test negative
Clinical narrative: d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hallucination, Herpes simplex test negative, Immunoglobulin therapy, Lumbar puncture, Morbid thoughts
Clinical narrative: d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging abdominal, Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Psychotic disorder, Soliloquy
Clinical narrative: d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Speech disorder, Streptococcus test negative, Thinking abnormal, Thyroxine normal, Treponema test negative
Clinical narrative: d/c summary: "Patient was floridly psychotic at start of her stay, hallucinating, speaking of herself in 3rd person, disoriented, agitated, bizzare speech with a morbid theme.  Because of some reported buccal sxs (yawning like mouth movements), and the morbid thinking with hallucinations anti NMDA encephalitis was entertained.  Additional w/u included neg urine drug screen, head CT, T4/TSH, syphilis, HIV, ceruloplasmin, Anti DNAse B and strep PCR throat, serum lactate. An LP was traumatic but tested neg for HSV and Enterovirus.  Acyclovir was started and stopped.   An MRI of brain was normal but no contrast used.   She was treated empirically with IVIG even before MRI and Pulse Solumedrol started 1gm/day x 5 days. We repeated LP to send for autoimmune encephalitis panel at clinic 8/5 as a more sensitive test.  This sample was not traumatic and had 10 WBC.   IGM and IGG for WNV were neg on this sample.  15 ml CSF was obtained with plenty of extra available for further testing if needed.  Clinic contacted Dr, and recommended some other testing (see pending).  She felt it unlikely by sx that this represented an infectious cause. She required doses of Ativan early in her course. Her sx improved dramatically by the 3rd day of Solumedrol and we no longer needed Ativan. She had only subtle sx by 8/8 with some odd ideations/recollections of events but by that time was eating, cooperative, socially engaging w/o any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person. Treating per the Protocol until the Enc 2 panel comes back negative.  After pulse solumedrol completed she started Prednisone 60mg/day until further instructions from peds neuro as outpatient.  IVIG would be tentatively scheduled for 8/18.  Rituximab is on hold and would only be given if testing positive for anti NMDAR encephalitis. Psych consulted prior to discharge, considered psych meds but felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis-- >prefer to not start psych meds yet and instead have close follow-up in psych clinic in parallel with peds neuro clinic follow-up.   On day of discharge pt much improved, behavior appropriate, walking around the room oriented with pleasant affect, brushing her hair after showering.  "