chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports #: 1908USA008892, 1908USA008893, 1908USA008894).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA008894: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports #: 1908USA008892, 1908USA008893, 1908USA008894).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA008894: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008892, 1908USA008894). ; Sender's Comments:  US-009507513-1908USA007782: US-009507513-1908USA008894: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008892, 1908USA008894). ; Sender's Comments:  US-009507513-1908USA007782: US-009507513-1908USA008894: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008892, 1908USA008894). ; Sender's Comments:  US-009507513-1908USA007782: US-009507513-1908USA008894: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008893, 1908USA008892).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA007782: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008893, 1908USA008892).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA007782: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abortion spontaneous, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008893, 1908USA008892).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA007782: US-009507513-1908USA008892:
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Human papilloma virus test positive, Infertility female, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008893, 1908USA008894).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA008894: US-009507513-1908USA007782:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: redness; slight rash; This case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included grover's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema and rash. The patient was treated with topical steroid nos (Steroid Ointment Nos). On an unknown date, the outcome of the erythema and rash were recovered/resolved.   It was unknown if the reporter considered the erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingrix 3 months ago and had redness and slight rash which appeared a month ago and cleared up. The patient used steroid topical ointment.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Pyrexia
Clinical narrative: Feel tired; Feel a bit feverish; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced tiredness and feeling hot. On an unknown date, the outcome of the tiredness and feeling hot were unknown.   It was unknown if the reporter considered the tiredness and feeling hot to be related to Shingrix.  Additional information received were as follows: The day before the reporting date, the patient received Shingrix. The patient experienced side effects which were not severe, but the patient definitely felt tired and a bit feverish. The patient asked whether Advil or Aleve be helpful.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Swelling
Clinical narrative: swelling; sore arm; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced swelling and pain in arm. On an unknown date, the outcome of the swelling and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling and pain in arm to be related to Bexsero.  Additional details were provided as follows: The reporting medical assistant was patient's mother. The age at vaccination was not reported. The medical assistant mentioned that the patient received Bexsero and experience swelling and had a sore arm for approximately 2 weeks. The reporter did not agree to follow up. This case linked with US2019AMR150098 and US2019AMR150108, reported by same reporter.
Sex: M
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: Swelling; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Menveo.  Additional details were provided as follows: The reporting medical assistant was patient's mother. The age at vaccination was not reported. The medical assistant mentioned that the patient experienced swelling after having been vaccinated with Menveo. This case linked with US2019AMR150108 and US2019AMR150092, reported by same reporter. The reporter did not agree to follow up.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; Swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm and swelling of limb. On an unknown date, the outcome of the pain in arm and swelling of limb were unknown.   It was unknown if the reporter considered the pain in arm and swelling of limb to be related to Bexsero.  Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The medical assistant mentioned that the patient had experienced a sore arm and swelling after having administered Bexsero. The reporter did not agree to follow up. This case linked with US2019AMR150098 and US2019AMR150092, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Ocular hyperaemia, Ophthalmic herpes simplex
Clinical narrative: Herpes simplex keratitis; extreme eye redness; eye irritation; This case was reported by a consumer via sales rep and described the occurrence of herpes simplex keratitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant), eye red and eye irritation. On an unknown date, the outcome of the herpes simplex keratitis, eye red and eye irritation were recovered/resolved.   It was unknown if the reporter considered the herpes simplex keratitis, eye red and eye irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he had never taken any non-prescribed drug nor he drank alcohol. In June 2019, 2 months before the reporting date, the patient received 1st dose of Shingrix and experienced extreme eye redness and irritation which lasted a week. The patient's son indicated that his eyes problem could be herpes simplex keratitis and advised against taking second dose. The patient felt that he should complete the second dose and that eye problem was tolerable condition, if it prevents shingles. The reporter consented for follow up. For tolerance to 2nd dose, refer case US2019AMR150992.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Red arm / Injection site redness; Arm hot to touch; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced redness at the site and on her entire left arm which was hot to touch for three weeks after the injection. The patient stated the intensity of the redness and heat remained the same for the first two weeks, and then gradually improved until it was resolved by the end of the third week. The reporter consented to follow up. The pharmacist did not had lot number of product available at the time of this call, but he did consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles 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, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporter had a patient that experienced shingle should the patient  receive the 2nd dose of Shingrix. The reporter did not consent to follow-up. This was obtained via chat and visitor disconnected when the reporter asked for credentials.
Sex: F
Vaccine: RAB
Symptoms: Accidental exposure to product, Exposure via skin contact, Immediate post-injection reaction, Injury associated with device
Clinical narrative: Injury via needle on palm of hand; Accidental occupational exposure to product; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a female patient who administered Rabies NVS (RabAvert) for prophylaxis to the patient.   On 12th August 2019, the patient received RabAvert. On 12th August 2019, immediately after receiving RabAvert, the patient experienced needle injury, accidental occupational exposure to product and exposure via skin contact. On an unknown date, the outcome of the needle injury, accidental occupational exposure to product and exposure via skin contact were unknown.   It was unknown if the reporter considered the needle injury to be related to RabAvert.  Additional details were received as follows: The age vaccination was not applicable for this report. The reporter stated that, the nurse was handling the Rabavert vaccine, and while disposing the needle in sharps container the needle flew back out and poked her in the palm surface of her hand. No further details were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pharyngeal swelling
Clinical narrative: throat was swelling; This case was reported by a other health professional via sales rep and described the occurrence of throat swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2019, the patient received the 1st dose of Shingrix. On 25th July 2019, less than a day after receiving Shingrix, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was unknown.   It was unknown if the reporter considered the throat swelling to be related to Shingrix.  Additional information received were as follows: The reporter stated that, the patient received the 1st dose and that evening had gone to emergency room because her throat was swelling. The patient would not be receiving the second dose of Shingrix, which led to incomplete course of vaccination. Emergency room visit was required. Limited information was available from the sales representative.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival pain, Glossodynia, Injection site erythema, Lip erythema, Lip pain
Clinical narrative: redness injection site; sensitive feeling in tongue; sensitivity in the roof of the mouth; sore gums; soreness in lips; swelling of the lips; redness of the lips; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, couple of days after receiving Shingrix, the patient experienced injection site erythema, sensitive tongue, sensitive mouth, soreness gum, lip soreness, lip swelling and lip redness. On an unknown date, the outcome of the injection site erythema was resolved with sequelae and the outcome of the sensitive tongue, sensitive mouth, soreness gum, lip soreness, lip swelling and lip redness were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, sensitive tongue, sensitive mouth, soreness gum, lip soreness, lip swelling and lip redness to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in left arm. The patient stated that a couple of days following the injection, she developed redness at the injection site that went away eventually. The patient also noticed sensitive feeling in her tongue and in the roof of her mouth. The patient also developed sore gums, soreness in the lips, and redness and swelling of the lips. The patient did not consent to follow up. The patient did not provide any additional information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oral pain
Clinical narrative: redness injection site; sensitive feeling in tongue; sensitivity in the roof of the mouth; sore gums; soreness in lips; swelling of the lips; redness of the lips; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, couple of days after receiving Shingrix, the patient experienced injection site erythema, sensitive tongue, sensitive mouth, soreness gum, lip soreness, lip swelling and lip redness. On an unknown date, the outcome of the injection site erythema was resolved with sequelae and the outcome of the sensitive tongue, sensitive mouth, soreness gum, lip soreness, lip swelling and lip redness were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, sensitive tongue, sensitive mouth, soreness gum, lip soreness, lip swelling and lip redness to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in left arm. The patient stated that a couple of days following the injection, she developed redness at the injection site that went away eventually. The patient also noticed sensitive feeling in her tongue and in the roof of her mouth. The patient also developed sore gums, soreness in the lips, and redness and swelling of the lips. The patient did not consent to follow up. The patient did not provide any additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: Extensive sweling of vaccinated limb; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable. The age group was captured as adult as per Shingrix indication.  The caller reported a few patients had severe redness and swelling from shoulder to elbow. The caller provided limited information and declined to provide patient-specific information as they were not directly patients of his, only people who had called him asking for more information about reactions. The reporter did not consent to follow up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Blistery Rash; Blister; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 43S97, expiry date 26th November 2021) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th August 2019, 3 days after receiving Shingrix, the patient experienced blistery rash and rash. On an unknown date, the outcome of the blistery rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the blistery rash and rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting that the patient experiencing a blistery rash after receiving Shingrix.There were more blisters present than rash, it was to the patient's rib cage and a little between her breast.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix years ago. The patient stated that, shed had every reaction that she could read online with the first dose of Shingrix vaccine. The patient had fever and chills that lasted for about 2 to 3 days. The patient did not want to answer any questions in regards to the adverse event and did not want to provide any demographic information.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Local reaction, Pyrexia
Clinical narrative: low fever; chills; Amplification of local reactions; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever, chills and local reaction. On an unknown date, the outcome of the fever, chills and local reaction were recovered/resolved.   It was unknown if the reporter considered the fever, chills and local reaction to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced amplification of local reactions, chills and low fever for almost 48 hours. The patient experienced no problems after 2nd dose of Shingrix. The physician was unable to provide patient or vaccine details, provided these reported events as general events reported by patients.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: bump at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. In August 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The caller was the patient's wife.  The patient received Shingrix and developed a bump and redness at the injection site. The caller did not provide any additional information. This case was linked with the case US2019149370, reported for patient's wife.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a physician via call center representative and described the occurrence of hives in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix. On 5th May 2019, 9 days after receiving Shingrix, the patient experienced hives. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient received Shingrix and developed hives, that are reported as ongoing and are only suppressed by taking antihistamines. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Redness left arm; red areas hot to touch; Fever; headache; had pain during the injection that went down her left arm; swollen lymph notes; This case was reported by a nurse via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received Shingrix (intramuscular). On 13th August 2019, several hours after receiving Shingrix, the patient experienced fever, headache, pain in arm and enlargement of lymph nodes. On 15th August 2019, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the fever and erythema of extremities were unknown and the outcome of the headache was resolved with sequelae and the outcome of the pain in arm, enlargement of lymph nodes and skin warm were recovering/resolving.   It was unknown if the reporter considered the fever, headache, pain in arm, enlargement of lymph nodes, erythema of extremities and skin warm to be related to Shingrix.  Additional information received were as follows: On 13th August 2019, the patient received Shingrix to her left deltoid at 2pm. The patient stated that she developed a fever just hours after the shot. The patient developed a headache the same night she had the injection but that it went away. The patient stated that she had pain during the injection that went down her left arm. Till the time of reporting patient was continuing to have pain to her left arm and swelling to her left axillary lymph nodes. On the day of reporting the patient noticed two red areas that are painful, red and hot to the touch. The patient stated that the first area was 4 inches down from the injection site and that it was about the size of a dime. The second area was about 5 inches down from the injection site and was ovular and about 3.5 inches wide or size of a half dollar. The patient called her pharmacist who told her to follow up with her healthcare professional but that she was on her way to another country. The patient consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Redness left arm; red areas hot to touch; Fever; headache; had pain during the injection that went down her left arm; swollen lymph notes; This case was reported by a nurse via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received Shingrix (intramuscular). On 13th August 2019, several hours after receiving Shingrix, the patient experienced fever, headache, pain in arm and enlargement of lymph nodes. On 15th August 2019, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the fever and erythema of extremities were unknown and the outcome of the headache was resolved with sequelae and the outcome of the pain in arm, enlargement of lymph nodes and skin warm were recovering/resolving.   It was unknown if the reporter considered the fever, headache, pain in arm, enlargement of lymph nodes, erythema of extremities and skin warm to be related to Shingrix.  Additional information received were as follows: On 13th August 2019, the patient received Shingrix to her left deltoid at 2pm. The patient stated that she developed a fever just hours after the shot. The patient developed a headache the same night she had the injection but that it went away. The patient stated that she had pain during the injection that went down her left arm. Till the time of reporting patient was continuing to have pain to her left arm and swelling to her left axillary lymph nodes. On the day of reporting the patient noticed two red areas that are painful, red and hot to the touch. The patient stated that the first area was 4 inches down from the injection site and that it was about the size of a dime. The second area was about 5 inches down from the injection site and was ovular and about 3.5 inches wide or size of a half dollar. The patient called her pharmacist who told her to follow up with her healthcare professional but that she was on her way to another country. The patient consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Developmental regression, Laboratory test abnormal
Clinical narrative: The child received vaccines at 13m of age, mom states that shortly after that, he had regression. He stopped talking. Per records, a visit at 20 months he appeared to be developing well, however.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperventilation, Musculoskeletal stiffness, Tetany
Clinical narrative: Hyperventilation and Tetany -> stiffness Pt Recovered
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Throat tightness
Clinical narrative: Ten minutes after shot patient felt throat was closing, no swelling of lips or tongue noted called 911 and sent patient to Hospital
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Blood test, Cognitive disorder, Echocardiogram, Scan brain
Clinical narrative: Woke up Sat. morn and could not comprehend/function, think of words or put a sentence.  I was taken to the ER @ hosp. and admitted where I was then released on the following Mon. afternoo
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound Doppler
Clinical narrative: Woke up Sat. morn and could not comprehend/function, think of words or put a sentence.  I was taken to the ER @ hosp. and admitted where I was then released on the following Mon. afternoo
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PATIENT CAME BACK TO THE OFFICE WITH A 5 X 6cm AREA OF REDNESS AND TENDERNESS RT LATERAL ARM
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Influenza like illness
Clinical narrative: Very painful arm at injection site. Swelling. Weak and tired feeling fluish, feverish. Wednesday night shivering and cold. Needed extra blanket and socks. By Friday much better.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Swelling
Clinical narrative: Very painful arm at injection site. Swelling. Weak and tired feeling fluish, feverish. Wednesday night shivering and cold. Needed extra blanket and socks. By Friday much better.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: severe headache, nausea, vomiting, fever ( temp not taken) lasting less than 12 hours. Mom called clinic the day after vaccination was given reporting symptoms and stating he had recovered at time of phone call. Patient's 2 sisters had similar reactions.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient called back the evening of the shot and said his arm was swollen, hard itched, and a rash was forming around the site of the injection.  Said it was unusual enough that he felt it should be reported.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Ear infection, Fatigue, Headache, Hypersomnia
Clinical narrative: 1. exhaustion - slept almost 20 hours after vaccination 2. 48 hours after vaccination mild ear infection 3. 96 hours after vaccination fever, intense ear infection, fever continued for 3 days. Infection required antibiotics and MILD INFECTION PERSISTS. WAITING AND WATCHING. 4. 9 days after vaccination a new headache with stiffness and pain in knees, mild fever (below 100). Could not bend knees without pain. Knee pain and stiffness lasted 48 hours, with a peak at about 24 hours. Headache lasted approximately 48 hours.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Joint stiffness, Pain, Pyrexia
Clinical narrative: 1. exhaustion - slept almost 20 hours after vaccination 2. 48 hours after vaccination mild ear infection 3. 96 hours after vaccination fever, intense ear infection, fever continued for 3 days. Infection required antibiotics and MILD INFECTION PERSISTS. WAITING AND WATCHING. 4. 9 days after vaccination a new headache with stiffness and pain in knees, mild fever (below 100). Could not bend knees without pain. Knee pain and stiffness lasted 48 hours, with a peak at about 24 hours. Headache lasted approximately 48 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: awaken that night, sweating, feeling sick and uncomfortable needed to take tylenol, next day felt chills and fatigue and was unable to engage in normal activity napped for 3 hours. Arm is still warm to touch and painful today 8-23-2019.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Middle insomnia, Pain in extremity, Skin warm
Clinical narrative: awaken that night, sweating, feeling sick and uncomfortable needed to take tylenol, next day felt chills and fatigue and was unable to engage in normal activity napped for 3 hours. Arm is still warm to touch and painful today 8-23-2019.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: Patient came to pharmacy 8/21/19 after getting immunizations 8/19/19. Patient states she was short of breath from the vaccines. Patient's left arm was red and slightly raised. Patient was told to use Benadryl and was given an ice pack. Patient was kept in pharmacy in chair for 45 mins to monitor symptoms since she was short of breath and refused to contact/go to the doctor's office or ER. Pharmacist contacted doctor on patient's behalf and he said he would contact her. Tried to contact patient 8/22/19 and 8/23/19 to see if symptoms resolved, but no answer.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Chills, Dizziness, Headache, Malaise, Pyrexia
Clinical narrative: Onset several days after vaccination of  chills, feeling unwell, headache, dizziness. Symptoms continued. Evaluated on 5 August by MD for fever and headache. Brought to ER. Admitted to hospital
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Increased blood glucose, arm soreness, redness at injection site, swollen injection site, fatigue, headache, muscle aches, low grade fever
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Increased blood glucose, arm soreness, redness at injection site, swollen injection site, fatigue, headache, muscle aches, low grade fever
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin Rash